Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA device recall Z-1233-2023 · posted 2023-03-08 · Open, Classified
Recall details
- Recalling firm
- Elekta Inc
- Reason for recall
- Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
- Action taken
- Elekta notified consignees of the issue on 02/28/2023 via email. Consignees were instructed to contact Elekta Care Support if assistance is needed to identify affected patients, post the recall information in a place accessible to all users until the action is complete, and complete and return the Important Field Safety Notice Acknowledgement form. Additionally, the issue is corrected in Monaco releases 5.40 and above. If you are running a 5.11.xx version, please contact Elekta Care Support to upgrade to a newer software version.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MUJ
- Quantity affected
- 2,020 units
- Distribution
- Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzeg
- Date initiated
- 2023-02-28
- Date posted
- 2023-03-08
- Location
- Saint Charles, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Monaco (K151233) | Impac Medical Systems, Inc. | 2015-07-07 |