https://github.com/advisoryops/advisoryopsAdvisories affecting FDA Class III (highest-risk) medical devicesTue, 27 Oct 2026 12:11:05 +0000en-ushttps://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0032-2014"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0032-2014"The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0. | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. | Bio-Rad Laboratories | Class Class IIIP0https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2021"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2021"It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01. | Neoprobe GDS Control Unit, Model Number NPCU3 | Devicor Medical Products Inc | Class Class IIIP0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36309https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36309Wed, 15 Dec 2004 00:00:00 +0000Historical FDA recall Z-0341-05 for Philips HeartStart MRx monitor/defibrillator models M3535A and M3536A. The recall concerns a possible delay in energy delivery when the sync function is enabled and the device switches from manual to AED mode. FDA lists software versions A.02.00 and lower in the code information. Philips notified customers by letter in December 2004, with interim risk mitigation pending correction by a company representative. The recall was initiated on 2004-12-15 and terminatP0https://api.fda.gov/device/recall.json?search=res_event_number:"31955"https://api.fda.gov/device/recall.json?search=res_event_number:"31955"Tue, 14 Sep 2010 00:00:00 +0000The device may disarm and not deliver shock when performing a Synchronized Cardioversion | Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A | Philips Medical Systems | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"30915"https://api.fda.gov/device/recall.json?search=res_event_number:"30915"Sat, 06 May 2006 00:00:00 +0000The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. | LIFEPAK 12 defibrillator/ monitors biphasic | Medtronic Emergency Response Systems, Inc. | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"34685"https://api.fda.gov/device/recall.json?search=res_event_number:"34685"Sun, 25 Jun 2006 00:00:00 +0000Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge. | Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982. | Cardiac Science Corporation | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"31212"https://api.fda.gov/device/recall.json?search=res_event_number:"31212"Wed, 08 Jun 2011 00:00:00 +0000The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition. | Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected). | Heartsine Technologies Inc | Device: Automated External Defibrillators (Non-WearablP0https://api.fda.gov/device/recall.json?search=res_event_number:"25286"https://api.fda.gov/device/recall.json?search=res_event_number:"25286"Tue, 27 May 2003 00:00:00 +0000Adverse events- suspected pseudoaneurysm | Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. | Cook Biotech, Inc. | Device: Implantable Pacemaker Pulse-Generator.P0https://api.fda.gov/device/recall.json?search=res_event_number:"27418"https://api.fda.gov/device/recall.json?search=res_event_number:"27418"Thu, 17 Feb 2005 00:00:00 +0000Potential for early depletion of Implantable Cardioverter Defibrillator battery. | Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. | Biotronik Inc | Device: Implantable Cardioverter Defibrillator (Non-Crt).P0https://api.fda.gov/device/recall.json?search=res_event_number:"32465"https://api.fda.gov/device/recall.json?search=res_event_number:"32465"Mon, 26 Mar 2012 00:00:00 +0000The vendor has released a non-invasive firmware update for several models of Implantable Cardioverter Defibrillators to address issues related to Skipped-Charge Shock and Sensor Noise Anomaly. It is important to ensure that these devices are updated promptly to maintain their proper functionality. Please check if your devices are affected and proceed with the upgrade as soon as possible. | Device: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D). | ImplanP0