DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704019 1704012 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039
  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:
Pro-Med Instruments Gmbh
Reason for Recall:
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

Product Codes/Lot Numbers:

Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704019 1704012 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039

Distribution:

Distributed in: US, CA, TX, TN, MS, GA, WV, OH, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2970-2018

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