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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Pro-Med Instruments Gmbh: 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.

Agency Publication Date: September 17, 2018
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Affected Products

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

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

Product: DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704012 1704019 1704037 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039 1709014

Product: DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704019 1704012 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704031 1704026 1704027 1704028 1704029 1704030 1704032 1704034 1704035 1704006 1704037 1704039

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80628
Status: Resolved
Manufacturer: Pro-Med Instruments Gmbh
Manufactured In: Germany
Units Affected: 3 products (30 units; 31 units; 31 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.