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Browse Device Recalls

160 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 160 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 160 FDA device recalls.

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DateProductReasonClassFirm
Mar 16, 2018 Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Mod... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic devic... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 14, 2018 Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen m... After continuous operation for more than one and a half days, the image on the large screen monit... Class II Philips Electronics North America Corporation
Feb 7, 2018 HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us... Update XL¿ device software to version A.03. This includes enhancements to the Operational Check... Class III Philips Electronics North America Corporation
Jan 29, 2018 Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America Corporation
Jan 29, 2018 Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America Corporation
Jan 4, 2018 Allura Xper systems with Certeray X-ray Generator located in regions with hig... There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these produc... Class II Philips Electronics North America Corporation
Jan 3, 2018 Intellivue iX Information Center Software - All PIIC iX Surveillance stations... Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable ... Class II Philips Electronics North America Corporation
Dec 20, 2017 Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: ... Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), mi... Class II Philips Electronics North America Corporation
Dec 11, 2017 digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/... It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may ... Class II Philips Electronics North America Corporation
Nov 17, 2017 IntelliVue X3 Patient Monitor. The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instea... Class II Philips Electronics North America Corporation
Oct 19, 2017 CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnos... The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with ... Class II Philips Electronics North America Corporation
Oct 5, 2017 Philips Network Firewall (Cisco ASA 5506), Model # 867098 Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic ma... Class II Philips Electronics North America Corporation
Sep 28, 2017 Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will... Class II Philips Electronics North America Corporation
Sep 20, 2017 Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar... Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do... Class III Philips Electronics North America Corporation
Aug 23, 2017 IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP... Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors Class II Philips Electronics North America Corporation
Aug 18, 2017 Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, ... When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurement... Class II Philips Electronics North America Corporation
Jul 17, 2017 ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units... Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from ... Class II Philips Electronics North America Corporation
Jul 14, 2017 Mobile Detector Holder - Stationary X-ray System (RF System). suitable for po... If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly ... Class II Philips Electronics North America Corporation
May 31, 2017 Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 7122... Tube arm assembly could fall down due to cracked welding joints Class II Philips Electronics North America Corporation
May 11, 2017 Philips DigitalDiagnost 3.1.x X-Ray System During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential is... Class II Philips Electronics North America Corporation
May 4, 2017 NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865... Manufacturing defect may cause localized heating, which may result in localized skin burn. Class II Philips Electronics North America Corporation
Mar 22, 2017 UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNI... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 The following systems are only affected if a Laird chiller is installed (11NC... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 6, 2017 Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Excha... Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mo... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These ... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These compu... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed The... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These comp... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 18, 2017 Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These co... During a bolus tracking procedure, no images were generated when the scan was completed, and the ... Class II Philips Electronics North America Corporation
Jan 17, 2017 Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 ... The monitor may not alarm appropriately for a pediatric or neonatal patient. Class II Philips Electronics North America Corporation
Dec 27, 2016 Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with In... May experience a loss of centralized monitoring. Class II Philips Electronics North America Corporation
Dec 9, 2016 Velara Generator with an old Firmware version used with Philips Allura Xper S... System may lock up. Class II Philips Electronics North America Corporation
Dec 9, 2016 Velara Generator with an old Firmware version used with the Philips Integris ... System may lock up. Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular ... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing tran... Possibility that a patient or user may be exposed to a very small level of touch current. Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-r... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GH... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Aug 26, 2016 HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A The handle can separate from the MRx housing due to breakage of mounts on the rear case. Class II Philips Electronics North America Corporation
Aug 12, 2016 PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732... A defect component of the Compano reader power supply can cause the power supply to burn and some... Class II Philips Electronics North America Corporation
Jul 26, 2016 IntelliVue Patient Monitor Product Usage: The monitors are indicated for ... If an affected Patient Monitor has been powered on continuously for several months, any displayed... Class II Philips Electronics North America Corporation
Jul 19, 2016 MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, ... The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... Class II Philips Electronics North America Corporation
Jul 19, 2016 UroDiagnost; x-ray system. Product Code: 708033 The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... Class II Philips Electronics North America Corporation
Jul 19, 2016 MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036 The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... Class II Philips Electronics North America Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.