CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
ROSA One 1 Brain Application recalled by Medtech Sas
Medtech Sas is recalling ROSA One 1 Brain Application, distributed nationwide in the US. The recall was initiated on 6 Jan 2020 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-1151-2020
- FDA event ID
- 84642
- Recalling firm
- Medtech Sas, Montpellier
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2020
- FDA classified
- 11 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Jan 2020 | Recall initiated by company | |
| 11 Feb 2020 | Classified by FDA | +36 days |
| 19 Feb 2020 | 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
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ROSA One 3.1 Brain Application
Where it was distributed
US Nationwide
Questions about this recall
Is ROSA One 1 Brain Application recalled?
Yes. Medtech Sas recalled ROSA One 1 Brain Application on 6 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1151-2020.
Why was it recalled?
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Which lots are affected?
Serial Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038; 3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043; 7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049; 8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052; 10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054; 11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057; 12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058.
Where was it sold?
US Nationwide
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.
More recalls from Medtech Sas
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | ROSA One 1 Brain application The device is intended recalled | Medtech Sas | Labeling Errors | Nationwide |
| Device | CLASS II | ROSA Brain 0 Application-Brain recalled by Medtech Sas | Medtech Sas | Device Malfunction | Nationwide |
| Device | CLASS I | Rosa Brain recalled by Medtech Sas | Medtech Sas | Foreign Material | Nationwide |
| Device | CLASS II | ROSA(TM) Robotized Stereotactic Assistant recalled by Medtech Sas | Medtech Sas | Device Malfunction | N/A |
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