Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external be
FDA device recall Z-0112-2016 · posted 2015-10-07 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
- Action taken
- The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 154 units
- Distribution
- Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
- Date initiated
- 2015-09-15
- Date posted
- 2015-10-07
- 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 |