Browse Device Recalls
6 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 6 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 6 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 7, 2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deli... | When editing the isocenter or the couch position of the plan while in the treatment workflow (in ... | Class II | Viewray Incorporated |
| Dec 24, 2015 | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | The system loaded a completion fraction in the incorrect order after a treatment interruption. | Class II | Viewray Incorporated |
| Aug 27, 2015 | MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for ste... | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling Syst... | Class II | Viewray Incorporated |
| May 7, 2015 | Treatment Planning and Delivery System Software version 3.6. ViewRay. Ind... | The software was failing to determine new patient locations if imaging is not enabled during trea... | Class II | Viewray Incorporated |
| Apr 1, 2015 | Patient Handling System (Motion Control Software), Product Usage: Indica... | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS... | Class II | Viewray Incorporated |
| Jan 15, 2015 | ViewRay System, Radiation Therapy System | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) ... | Class II | Viewray Incorporated |
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.