Browse Device Recalls
313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 313 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 313 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 25, 2016 | Brilliance iCT Product Usage: Computed Tomography X-ray systems intended... | Failure to correctly document the installation of four M12 Bolts into the system rotor. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 18, 2016 | FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device... | There's a potential for liquid penetration into the back side of the front control panel of the X... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cr... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | Philips Spectral CT Applications supports viewing and analysis of images at e... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728232 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 128 728323 | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cr... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce ... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728231 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity CT Computed Tomography X-ray system, Model 728326 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | IQon Spectral CT Computed Tomography X-ray system, Model 728332 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Brilliance ICT SP Computed Tomography X-ray system, Model 728311 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core Computed Tomography X-ray system, Model 728321 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Brilliance iCT Computed Tomography X-ray system, Model 728306 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-r... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance BigBore Radiology CT Model number 728244 Product Usage: Comput... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Compu... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2016 | Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomog... | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Ingenuity Flex, model # 728317; Intended to produce cross- sectional images ... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Ingenuity Core, model # 728326; Intended to produce cross- sectional images ... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Ingenuity Core 128, model #728323; Intended to produce cross- sectional imag... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- se... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 21, 2016 | Brilliance iCT model #728306; Intended to produce cross- sectional images of... | Supplier design change contributed to a thinner plastic which was used as part of the cover on th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 14, 2016 | Big Bore Oncology tomography X-ray system scanner, model number 728243. The... | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 14, 2016 | Big Bore Radiology tomography X-ray system scanner, model number 728244. Th... | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView X, model #882478; gamma camera designed for single or dual detecto... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Upgrade Model 882454 | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to pr... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended t... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... | Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... | Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core Computed Tomography X-ray systems is intended to produce cross... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produ... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
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.