Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2972-2018 — DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

U.S. FDA — Device Enforcement · Germany · 2018-07-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2972-2018
Date of alert
2018-07-05
Country / jurisdiction
Germany
Risk level
Class I
Risk type
recall
Brand
Pro-Med Instruments Gmbh
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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