Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...Read More
WARNING LETTER Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 685606 Globus Medical, Inc. Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403 Dates: February 15, 2024, through March 7, 2024 Inspection Issue(s): These violations include, but are not limited to, the...Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/16/2024 Class II PRODUCT Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump. Recall Number: Z-2581-2024 REASON: The Spectrum WBM may fail to auto-document...Read More
Company: Biointellisense Inc. Date of Enforcement Report: 8/14/2024 Class II PRODUCT BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. Recall Number: Z-2616-2024 REASON: Software anomaly causing the skin temperature...Read More
Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/9/2024 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Recall Number: Z-2544-2024 REASON: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the...Read More
Company: Philips North America Llc Date of Enforcement Report: 8/5/2024 Class II PRODUCT IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Recall...Read More
Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/2/2024 Class: I PRODUCT CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent...Read More
Company: Beckman Coulter Mishima K.K. Date of Enforcement Report: 7/31/2024 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Recall Number:...Read More
I got a cancellation notice today for my driver’s license renewal appointment. Reason? “Internet down statewide and will not be resolved today.” The outage was actually worldwide. You probably saw news reports or were affected by it. A software update by cybersecurity firm Crowdstrike caused some Windows systems to stop working. Outages didn’t just affect...Read More
WARNING LETTER Criticare Technologies, Inc was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 686915 Criticare Technologies, Inc. 6901 TPC Drive, Suite 300Orlando, FL 32822United States July 12, 2024 Inspection Dates: March 21, 2024, through May 10, 2024 Inspection Issue(s): These violations include, but are not limited...Read More
Company: Philips Respironics, Inc. Date of Enforcement Report: 5/23/2024 Class I PRODUCT OmniLab Advanced+ (OLA+) Ventilator Recall Number: Z-1817-2024 REASON: Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to...Read More
Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...Read More
Company: Echonous Inc. Date of Enforcement Report: 7/10/2024 Class II PRODUCT Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall Number: Z-2325-2024 REASON: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 7/3/2024 Class II PRODUCT BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Recall Number: Z-2262-2024 REASON: Due to a software issue there is the potential that the PC unit may not connect to the server which could impact wireless data transmission to and...Read More
Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 6/26/2024 Class II PRODUCT Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 Recall Number: Z-2214-2024 REASON: Siemens Healthineers has...Read More
Company: Blue Belt Technologies, Inc Date of Enforcement Report: 6/11/2024 Class II PRODUCT CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT – UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence...Read More
Company: Abbott Medical Group Date of Enforcement Report: 6/7/2024 Class I PRODUCT Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device Recall Number: Z-1921-2024 REASON: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in...Read More
Company: Nihon Kohden America Inc Date of Enforcement Report: 6/6/2024 Class II PRODUCT BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility Recall Number: Z-2025-2024 REASON: Due to software issue...Read More
WARNING LETTER Techlem Medical Corporation was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 671395 Techlem Medical Corporation Mississauga ON December 26, 2023 Inspection Dates: June 19, 2023, through June 22, 2023 Inspection Issue(s): These violations include, but are not limited to, the following: 1. Failure...Read More
WARNING LETTER Trexo Robotics Holdings, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 673150 Cue Health, Inc. San Diego, CA February 7, 2024 Inspection Dates: on June 3 through June 5, 2023 Inspection Issue(s): “the Trexo devices are adulterated under section 501(f)(1)(B) of...Read More
Company: Verathon, Inc. Date of Enforcement Report: 6/4/2024 Class II PRODUCT Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor Recall Number: Z-2021-2024 REASON: Due to software issues, there is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. RECALLING...Read More
SoftwareCPR’s partner Dr. Peter Rech convened the IEC TC62/SC62D/MT23 Infusion Pumps working group meeting held from April 22nd to 26th at the AAMI headquarters in Arlington, VA. The attendants included international experts and guests joining from governmental agencies, infusion pump manufacturers, test houses, and clinical research institutions. Progress was made on a variety topics: Pump...Read More
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 onsite with group exercises, quizzes, examples, Q&A.
Instructor: Brian Pate
Next public offering: TBD
Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.
Registration Link:
TBD
Being Agile & Yet Compliant (Public or Private)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!
Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!
2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.
Instructors: Mike Russell, Ron Baerg
Next public offering: TBD
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)
