TY - JOUR AB - VOLUME 54 • NO 13 www.biomedicalsafetystandards.com JULY 15, 2024 BIOMEDICAL SAFETY & STANDARDS Concise News Reports on Medical Device Safety BS&S FEATURE In This Issue FDA Amplifies Concerns About Getinge Recalls & Field Corrections—Class I Cardiovascular Adverse Events Tandem Diabetes Care Apple iOS t:connect ver 2.7 Mobile App . . . . . . . . . . . . . . . .75 1 he FDA is notifying health care providers and facilities Route 92 Medical Tabout ongoing safety and quality concerns regarding Catheters . . . . . . . . . . . . . . . . . 76 certain cardiovascular medical devices manufactured by Getinge/Maquet. These devices include the Getinge/ Biomerieux Vitek 2 Antimicrobial Sensitivity Maquet/Datascope Cardiosave Hybrid and Rescue Intra- Test Kits . . . . . . . . . . . . . . . . . . .77 Aortic Balloon Pump (IABP) devices, and the Getinge/ SonarMed Airway Sensors Maquet Cardiohelp system and HLS Sets. and Monitors . . . . . . . . . . . . . . .77 Health care facilities are advised to consider transitioning away from the use of these devices and seek alternative TI - Philips Uninterruptable Power Supply JF - Biomedical Safety Standards DO - 10.1097/01.bmsas.0001025364.37161.13 DA - 2024-07-15 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/philips-uninterruptable-power-supply-BLfdkYHnSt SP - 77 EP - 77 VL - 54 IS - 13 DP - DeepDyve ER -