medical Class II Updated 2020-08-19

Brainlab AG recalls BRAINLAB Curve; Model/catalogue (article) numbers for Curve

Recalled Product

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011


Hazard / Issue

Incorrect manufacturer calibration

Issued by

FDA

Affected States: CA, TX, RI
Lot/Code Info: CURVE 1.1 DUAL NAVIGATION STATION, Serial Numbers: 3911619001-19901, S/N of affected NDI Camera: P7-21527 1173019001-19901B, S/N of affected NDI Camera: P7-21173 1444519001-19901B, S/N of affected NDI Camera: P7-21183 1937319001-19901B, S/N of affected NDI Camera: P7-21325 2201419001-19901B, S/N of affected NDI Camera: P7-21324 2456219001-19901B, S/N of affected NDI Camera: P7-21382 3524219001-19901B, S/N of affected NDI Camera: P7-21414 5379420001-19901B, S/N of affected NDI Camera: P7-21830 5609520001-19901B, S/N of affected NDI Camera: P7-21892 6968320001-19901B, S/N of affected NDI Camera: P7-20390 4593720001-19901B, S/N of affected NDI Camera: P7-21655 7850820001-19901B, S/N of affected NDI Camera : P7-22083 6393920001-19901B, S/N of affected NDI Camera: P7-21895 3844314001-19901B, S/N of affected NDI Camera: P7-21449 CURVE DUAL DISPLAY NAVIGATION STATION, Serial Numbers: 0824912001-19900, S/N of affected NDI Camera: P7-21890 3894613001-19900, S/N of affected NDI Camera: P7-21780 4387415001-19900, S/N of affected NDI Camera:P7-07290 CURVE SINGLE DISPLAY NAVIGATION STATION, Serial Number: 5762713001-19905, S/N of affected NDI Camera: P7-10719
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