Tag

recall

Software Recall

Company: Hospira, Inc.Date of Enforcement Report: 12/8/2010 Class ll: PRODUCT EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5. Recall # Z-0126-2011 REASON The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin. RECALLING FIRM/MANUFACTURER Recalling...
Read More
Company: CareFusion Corp..Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Recall # Z-0492-2011 REASON Issue: PC Unit model 8000, when used with Pump or Syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver...
Read More
Company:Instrumentation Laboratory Co.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis...
Read More
Company:Philips Medical Systems Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0124-2011;...
Read More
Company: Philips Healthcare.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0133-2011 REASON Philips Healthcare has decided to recall the Computed Tomography X-Ray System...
Read More
Company: Varian MedicalDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Varian brand TrueBeam and TrueBeam STx, Model Number: TMX- H19. Recall # Z-0106-2011 REASON Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects “Apply Shift” and presses Motion Enable buttons. This can result in the...
Read More
Company: Impac Medical Systems IncDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. Recall # Z-0159-2011 REASON Mistreatment–...
Read More
Company: GE Healthcare ITDate of Enforcement Report 12/1/2010 Class ll: PRODUCT GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-0123-2011 REASON Instrument...
Read More
Company: Medtronic Inc.Date of Enforcement Report 12/1/2010 Class ll: PRODUCT 1) Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that...
Read More
Company: SCC Soft ComputerDate of Enforcement Report 11/24/2010 Class ll: PRODUCT SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. Recall # Z-0088-2011 REASON Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a...
Read More
Company: Impac Medical Systems, Inc. Date of Enforcement Report 11/24/2010 Class ll: PRODUCT Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class 11b. Recall # Z- 0076-2011 REASON Software issue; matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different...
Read More
Company: Verathon, Inc. Date of Enforcement Report 11/17/2010 Class ll: PRODUCT 1) BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into...
Read More
Company:Baxter Healthcare, Corp Date of Enforcement Report 11/17/10//2010 Class l: PRODUCT ) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z-0001-2011; 2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes: 2M 8153 and 2M 8163. Recall # Z-0002-2011; REASON The FDA sent a letter to Baxter on...
Read More
The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
Read More
Company: Beckman Coulter, Inc. Date of Enforcement Report 11/10/2010 Class ll: PRODUCT UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other...
Read More
Company: International Technidyne Corp Date of Enforcement Report 11/10/2010 Class lll: PRODUCT Integrated Data Management System – Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010 REASON A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and...
Read More
Company: AGFA Corp. Date of Enforcement Report 10/27//2010 Class ll: PRODUCT IMPAX CV Results Manager/Results Manager Administration Tool. Model No. L9M2100. Recall # Z-2112-2010 REASON Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter on June...
Read More
Company: GE HealthcareDate of Enforcement Report 10/27//2010 Class ll: PRODUCT GE Healthcare, CARESCAPE” Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE ” Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and...
Read More
Company: Sorin Biomedica C.R.M Date of Enforcement Report 9/29//2010 Class ll: PRODUCT Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Recall # Z-2579-2010 REASON The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and...
Read More
Company: Philips Medical Systems North America Co. Date of Enforcement Report 9/22//2010 Class ll: PRODUCT DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. Recall # Z-2422-2010 REASON When...
Read More
Company: Medtronic Inc Date of Enforcement Report 8/25//2010 Class ll: PRODUCT Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The...
Read More
Company: GE Healthcare It. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT 1) GE Centricity PACS-IW software. Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1402-201; 2)GE Centricity Web Diagnostic (WebDX) software; Device that receives stores and communicates medical images and data from various imaging sources. Recall...
Read More
Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010 REASON Smiths...
Read More
Company: Haag-Streit USA Inc. Date of Enforcement Report 7/27//2010 Class ll: PRODUCT UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations...
Read More
Company: Bio-Rad Laboratories, In Date of Enforcement Report 7/21//2010 Class ll: PRODUCT 1) VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. Recall # Z-1901-2010; 2) VARIANT II TURBO Hemoglobin...
Read More
Company: Haag-Streit USA Inc. Date of Enforcement Report 7/21//2010 Class ll: PRODUCT Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal. Recall # Z-1897-2010. REASON...
Read More
Company: Alcon Laboratories Date of Enforcement Report 4/30//2010 Class l: PRODUCT CONSTELLATION Vision System REASON Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause...
Read More
Company:FHC, Inc,.Date of Enforcement Report 6/30//2010 Class ll: PRODUCT FHC micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog # MT-GL4K. Int. This version of software was released in August 2009. Recall # Z-1143-2010 REASON The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to...
Read More
Company:PerMedics, Inc.,.Date of Enforcement Report 6/23//2010 Class ll: PRODUCT Odyssey Intended use: Radiation treatment planning system. Recall # Z-1609-2010 REASON Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter...
Read More
Company:Abbott Laboratories, IncDate of Enforcement Report 6/15//2010 Class:ll PRODUCT ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated:...
Read More
Company:Mckesson Medical ImagingDate of Enforcement Report 6/15//2010 Class:ll PRODUCT Voiceware clip software update to certain Horizon Medical Imaging Systems. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems. Recall # Z-1735-2010 REASON Voice Clip issue: When the user is...
Read More
Company:GE Healthcare LLC.Date of Enforcement Report 6/9/2010 Class:ll PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic...
Read More
Company:GE Healthcare LLC.Date of Enforcement Report 6/2/2010 Class:ll PRODUCT 1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010; 2) GE Healthcare, Innova 3100 IQ: GE Innova 3100...
Read More
Company:Vital Images, Inc.Date of Enforcement Report 5/26//2010 Class:ll PRODUCT Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010 REASON Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea...
Read More
Company:Animas Corp.Date of Enforcement Report 5/26//2010 Class:lll PRODUCT One Touch Ping Insulin Pump using ezManager Max diabetes management software. Recall # Z-1560-2010 REASON Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food...
Read More
Company:ZOLL Medical Corp.Date of Enforcement Report 5/19//2010 Class:ll PRODUCT ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-1547-2010 REASON Device issued Shock Advised message but failed...
Read More
Company:Optovue Inc.Date of Enforcement Report 5/12//2010 Class:ll PRODUCT Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an...
Read More
CompanyCarefusionDate of Enforcement Report 4/28//2010 Class:ll PRODUCT NicoletOne vEEG System. Recall # Z-1256-2010 REASON CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. The field correction involves providing users with instructions for removing the subject protocols and verifying the deletion has...
Read More
Company: Baxter Healthcare CorpDate of Enforcement Report 4/21//2010 Class:ll PRODUCT Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010 REASON Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw...
Read More
Company: Ge Healthcare ItcDate of Enforcement Report 4/21//2010 Class:ll PRODUCT 1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations....
Read More
Company:Picis IncDate of Enforcement Report 4/15//2010 Class:ll PRODUCT CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010 REASON Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic...
Read More
Company:Toshiba American Medical Systems Inc.Date of Enforcement Report 3/31//2010 Class:ll PRODUCT 1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010; 2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010; 3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010 REASON Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A;...
Read More
Company:R. O. Golden & Co., IncDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Image Consultant (IC) Software. Recall # Z-1176-2010 REASON Software not validated. RECALLING FIRM/MANUFACTURER Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA, by letters on February 5, 2010. Manufacturer: Unique Media, Canton, PA. Firm initiated recall is ongoing. VOLUME OF PRODUCT...
Read More
Company:Haemonetics Software SolutionsDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Surround System software. Recall # B-0737-10 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solutions, Rosemont, IL, by e-mail on July 25, 2008. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 35 units DISTRIBUTION DC, FL, HI, IL, IN,...
Read More
Company:Beckman Coulter Inc.Date of Enforcement Report 3/17/2010 Class:l PRODUCT 1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean...
Read More
Company:Baxter Healthcare Corporation.Date of Enforcement Report 3/4/2010 Class:l PRODUCT Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1990 REASON Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume...
Read More
Company:Remel, Inc.Date of Enforcement Report 3/3//2010 Class:ll PRODUCT ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of...
Read More
Company:Cybernet Systems CorpDate of Enforcement Report 3/3/2010 Class:ll PRODUCT 1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data...
Read More
Company:Sendx Medical IncDate of Enforcement Report 2/17/2010 Class:ll PRODUCT ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The...
Read More
Company:Stryker ImagingDate of Enforcement Report 2/17/2010 Class:ll PRODUCT Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010 REASON Firm has determined Guardian Services does not contain 100% data backup for...
Read More
1 46 47 48 49 50 64

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 


 

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.