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
    • 19901
    • 19901B
    • 19900
    • 19905
  • 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.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 27, 2021 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.