Reported Jan 17, 2018 · Terminated
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision…
Brainlab AG
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: Brainlab AG · Olof-Palme-Strasse 9 · Munich, N/A · N/A
Is this the product you have?
- Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration
- Kit for C-arm Zeihm Vision RFDAdapter Left
- Lot codes and dates
- Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
- Amount recalled
- 80 devices total
Where it was sold
Why it was recalled
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
This product could cause temporary or reversible health problems — stop using it.
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