🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 16, 2020 Brainlab AG Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Brainlab AG
Reason for Recall:
Incorrect manufacturer calibration
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: CA, TX, RI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2792-2020

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