🔍 RecallPedia

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

Class I - Dangerous
🏥 Medical Devices Recalled: November 16, 2017 Brainlab AG Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
  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:
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.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

Product Codes/Lot Numbers:

Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0320-2018

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