Reported Feb 19, 2020 · Terminated
ROSA One 3.1 Brain Application
Medtech Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDTECH SAS · 900 Rue Du Mas De Verchant · Montpellier · N/A
Is this the product you have?
- ROSA One 3.1 Brain Application
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 03760244030948BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037 2 03760244030948BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038 3 03760244030948BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039 4 03760244030948BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040 5 03760244030948BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041 6 03760244030948BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043 7 03760244032492BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049 8 03760244032492BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050 9 03760244032492BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052 10 03760244032492BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054 11 03760244032492BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057 12 03760244032492BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058. - Amount recalled
- 39 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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