CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Monaco Radiation Treatment Planning System (RTP) System recalled
Elekta is recalling Monaco Radiation Treatment Planning System (RTP) System, distributed nationwide in the US. The recall was initiated on 23 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2409-2019
- FDA event ID
- 83604
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2019
- FDA classified
- 27 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Aug 2019 | Recall initiated by company | |
| 27 Aug 2019 | Classified by FDA | +4 days |
| 4 Sep 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Product as listed by the FDA
Monaco Radiation Treatment Planning System (RTP) System
Where it was distributed
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Questions about this recall
Why was it recalled?
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Which lots are affected?
Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
Where was it sold?
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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