Reported Aug 19, 2020 · Terminated
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve:…
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-str. 9 · Munich, N/A · N/A
Is this the product you have?
- BRAINLAB Curve; Model/catalogue (article)
- numbers for Curve
1990119901B1990019905
- UDI (GTIN) for Curve04056481138011
- Lot codes and dates
- CURVE 1.1 DUAL NAVIGATION STATION
- Serial Numbers3911619001-19901
- S/N of affected NDI CameraP7-21527 1173019001-19901B
- S/N of affected NDI CameraP7-21173 1444519001-19901B
- S/N of affected NDI CameraP7-21183 1937319001-19901B
- S/N of affected NDI CameraP7-21325 2201419001-19901B
- S/N of affected NDI CameraP7-21324 2456219001-19901B
- S/N of affected NDI CameraP7-21382 3524219001-19901B
- S/N of affected NDI CameraP7-21414 5379420001-19901B
- S/N of affected NDI CameraP7-21830 5609520001-19901B
- S/N of affected NDI CameraP7-21892 6968320001-19901B
- S/N of affected NDI CameraP7-20390 4593720001-19901B
- S/N of affected NDI CameraP7-21655 7850820001-19901B
- S/N of affected NDI CameraP7-22083 6393920001-19901B
- S/N of affected NDI CameraP7-21895 3844314001-19901B
- S/N of affected NDI CameraP7-21449 CURVE DUAL DISPLAY NAVIGATION STATION
- Serial Numbers0824912001-19900
- S/N of affected NDI CameraP7-21890 3894613001-19900
- S/N of affected NDI CameraP7-21780 4387415001-19900
- S/N of affected NDI CameraP7-07290 CURVE SINGLE DISPLAY NAVIGATION STATION
- Serial Number5762713001-19905
- S/N of affected NDI CameraP7-10719
- Amount recalled
- 18 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
Why it was recalled
Incorrect manufacturer calibration
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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