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Terminated

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

FDA Recall Z-2972-2018 · Posted 2018-09-17

Recalling FirmPro-Med Instruments Gmbh
Recall StatusTerminated
Product CodeHBL
Date Initiated2018-07-05
Date Terminated2020-11-19
Product Quantity31 units

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.

Firm Action

The firm initiated the recall by email on 07/05/2018. This stage is only relevant for hospitals / users who are in possession with concerned products of two different revisions (mix-up): a) Discontinue the use of the combination and quarantine the concerned products b) Contact pro med instruments for further instructions relating to temporary replacement possibilities

Root Cause

Component change control

Distribution Pattern

Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032331DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)Pro-Med Instruments GmbH · 2003-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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