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
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/24/2024 Class II PRODUCT Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Recall Number: Z-1895-2024 REASON: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does...Read More
Company: Stryker Leibinger GmbH & Co. KG Date of Enforcement Report: 5/23/2024 Class II PRODUCT 8000-021-002, Scopis ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic...Read More
Company: Tornier S.A.S. Date of Enforcement Report: 5/22/2024 Class II PRODUCT Stryker Blueprint Software, Catalog #BPUE001 Recall Number: Z-1883-2024 REASON: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval. RECALLING FIRM/MANUFACTURER: Tornier S.A.S....Read More
Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: May 06, 2024 Class I PRODUCT t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274 Recall Number: Z-1609-2024 REASON: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 5/9/2024 Class I PRODUCT Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Recall Number: Z-1776-2024 REASON: Due to a software issue, there is the potential for...Read More
WARNING LETTER CMS# 675673 Cue Health, Inc. San Diego, CA May 9, 2024 Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023. Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example: Evidence obtained during the inspection demonstrated that your...Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/1/2-24 Class II PRODUCT RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System Recall Number: Z-1742-2024 REASON: Potential for reported SSD to be too high. RECALLING FIRM/MANUFACTURER: RAYSEARCH LABORATORIES AB VOLUME OF PRODUCT IN COMMERCE: 9 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries of Algeria,...Read More
Company: SonarMed Inc Date of Enforcement Report: April 19, 2024 Class I PRODUCT AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. Recall Number: Z-1426-2024 REASON: SonarMed Inc. is recalling the SonarMed Airway monitoring system because of a software issue resulting in failure to detect a partial obstruction within 2.5mm sensors...Read More
