Reported Nov 3, 2021 · Ongoing
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments…
Medtech Sas
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 · N/A
Is this the product you have?
- ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
- Lot codes and dates
- Serial NumbersUS:
115 of 115 codes
BS16904BS16905BS16906BS16909BS16910BS16911BS16912BS16913BS16914BS16915BS16916BS16917BS16918BS16921BS16923BS16925BS17930BS17934BS17935BS17936BS17937BS18900BS18901BS18924BS18931BS18938BS18939BS18940BS18942BS18943BS18945BS18946BS18947BS18948BS18949BS18950BS18951BS18952BS18953BS18954BS18955BS18956BS18957BS18958BS18959BS18960BS18961BS18962BS18963BS18964BS18965BS18966BS18967BS18968BS18969BS18970BS18971BS18972BS18973BS18974
- BS21121 BS21129 BS21137 BS21138 OUS
BS15902BS15903BS16007BS16919BS16928BS16929BS17008BS17010BS17013BS17021BS17022BS17023BS18024BS18026BS18027BS18028BS18030BS18031BS19032BS19033BS19034BS19035BS19036BS19042BS19051BS19056BS19062BS19064BS20068BS20069BS20070BS20071BS20074BS20075BS20076BS20077BS20078BS20082BS20084BS20085BS20090BS20095BS20098BS20099BS20102BS20105BS20106BS21108BS21109BS21114BS21124BS21128BS21132BS21133BS21134
- Serial NumbersUS:
- Amount recalled
- 119 (US); 55 (OUS)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
Using this product could cause serious injury, illness or death — stop using it now.
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