Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/16/2013 Class ll: PRODUCT ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Recall Number Z-0645-2013 REASON Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect...Read More

Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Recall Number Z-0632-2013 REASON Horiba Medical is...Read More

Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urine....Read More

Company: Abbott Molecular Date of Enforcement Report 1/9/2013 Class ll: PRODUCT Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL...Read More

Company: Mindray DS USA Date of Enforcement Report 1/9/2013 Class ll: PRODUCT DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network...Read More

http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdfRead More

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdfRead More

/Docs/FDA-PMAFilingAcceptanceGuidance123112.pdfRead More

/Docs/FDAeCopyFinalGuidance123112.pdfRead More

This is one of the first mobile medical app recallsl we have seen posted. It is for an app that was only intended to be released in Brazil but was published on the iPhone store and available in the U.S. Its intended use is diabetes education. The full recall excerpt is available on our Recalls...Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland. Recall Number Z-0614-2013 REASON Certain COBAS AmpliPrep instruments...Read More

Company: sanofi-aventis US, Inc.. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. Recall Number Z-0609-2013 REASON Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as...Read More

AAMI and FDA held a two day event Oct 2-3, 2012, as a summit on interoperability. 260 people attended. AAMI has authorized widespread distribution of the proceedings document from this event (see the link provided). Interoperability Summit 2012Read More

Company: GE Healthcare LLC. Date of Enforcement Report 12/26/12 Class ll: PRODUCT GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/26/12 Class ll: PRODUCT Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Recall Number Z-0485-2013...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. Recall Number Z-0492-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data. Recall Number Z-0493-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older),...Read More

Company: Mindray DS USA Date of Enforcement Report 12/19/12 Class ll: PRODUCT DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable)....Read More

Company: Roche Molecular Systems Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Recall Number Z-0491-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/12/12 Class ll: PRODUCT Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System. Recall Number Z-0465-2013 REASON Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 12/12/12 Class l: PRODUCT The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The...Read More

Company: Philips Healthcare Inc. Date of Enforcement Report 12/12/12 Class ll: PRODUCT Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics.Recall Number Z-0475-2013 REASON With Digital Diagnost R2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/12/12 Class ll: PRODUCT Siemens Mobilette Mira, intended use as Mobile x-ray system. Recall Number Z-0480-2013 REASON There is a risk of lost images during examination. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 10/10.2012. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

/docs/SCPRed/SoftwareCPR-newsletter1212.pdfRead More

The Global Harmonization Task Force revision of its guidance on Essential Principles of Safety and Performance of Medical Devices is at the link provided. GHTF Essential Principles. It includes requirements for software that are similar to the European Union’s essential requirements relating to software.Read More

The GHTF is ending and will be replaced by a regulator-only organization, the International Medical Device Regulators Forum (IMDRF). This is the closing statement by the GHTF: GHTF-Closing-Statement.Read More

Company:GE Healthcare LLC Date of Enforcement Report 12/5/12 Class ll: PRODUCT GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is...Read More

Company:Kimberly-Clark Corporation Date of Enforcement Report 12/5/12 Class ll: PRODUCT Kimberly-Clark Patient Warming System – Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. Recall Number Z-0451-2013 REASON Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately RECALLING FIRM/MANUFACTURER Kimberly-Clark Corporation, Roswell,...Read More

http://1.usa.gov/18xZlGrRead More

A 2003 computer science thesis done at the University of York entitled “The Safety of Software — Constructing and Assuring Arguments” is at the link provided. Software Safety Cases – PhD ThesisRead More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 200290,, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More

Company: Mako Surgical Corporation Date of Enforcement Report 11/28/12 Class ll: PRODUCT The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill...Read More

Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software – Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12. Recall Number B-0101-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 7/24/12 Voluntary:...Read More

Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13. Recall Number B-0102-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 8/20/12 Voluntary: Firm Initiated recall is ongoing...Read More

Company:Sendx Medical Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained...Read More

Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. Recall Number Z-0251-2013 REASON The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. RECALLING FIRM/MANUFACTURER...Read More

Company:Sechrist Industries Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Recall Number Z-0208-2013 and Z-0209-2013 REASON Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with...Read More

Company:Philips Medical Systems Date of Enforcement Report 11/14/12 Class ll: PRODUCT Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3...Read More

Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Laboratory, version 7.0 not available. Recall Number Z-0250-2013 REASON Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. RECALLING FIRM/MANUFACTURER Sunquest Information...Read More

AAMI/CDV-1 62366:2007/A1 (IEC/SC62A/826/CDV) — Medical devices – Application of usability engineering to medical devices, Amendment 1. This amendment is out for comment and addresses legacy user interfaces and 62366 conformance for User Interfaces of Unknown Provenance (UOUP). The 62366 amendment draft can now downloaded free from AAMI. Go to the AAMI web site at the...Read More

Company:Heartsine Technologies, Limited Date of Enforcement Report 11/7/12 Class ll: PRODUCT HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation. Recall...Read More