Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam rad
FDA device recall Z-0181-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Unintended update of Dose and MU and Incorrect Assignment of Bolus.
- Action taken
- Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 154
- Distribution
- CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
- Date initiated
- 2015-10-16
- Date posted
- 2015-10-30
- Date terminated
- 2017-04-04
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Monaco (K151233) | Impac Medical Systems, Inc. | 2015-07-07 |