Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 28, 2023 | Monaco RTP System. Used to make treatment plans for patients with prescr... | Re-optimization, after adding contours without forced density outside the external structure, may... | Class II | Elekta Inc |
| Sep 14, 2021 | Elekta Monaco - Product Usage: used to make treatment plans for patients with... | Contour changes can be saved on an unintended image set. In addition, these contour edits do not ... | Class II | Elekta Inc |
| Jul 26, 2021 | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan i... | Class II | Elekta Inc |
| Apr 16, 2020 | Elekta MONACO RTP Sytem, radiation treatment planning software system - Produ... | The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour... | Class II | Elekta Inc |
| Mar 30, 2020 | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vant... | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking ... | Class II | Elekta Inc |
| Nov 22, 2019 | Monaco Radiation Treatment Planning System (RTP) System | Monaco is using the incorrect energy when optimizing and calculating dose. | Class II | Elekta Inc |
| Sep 4, 2019 | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Sep 4, 2019 | Monaco RTP System, 5.50/5.51, radiation treatment planning system Product ... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Jul 3, 2019 | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... | Class II | Elekta Inc |
| Sep 1, 2017 | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. | Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to... | Class II | Elekta 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.