medical Class I Updated 2018-09-26

Pro-Med Instruments Gmbh recalls DORO LUCENT Base Unit, REF 1101.021 Headrest System used in

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, TX, TN, MS, GA, WV, OH

Lot/Code Info: 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

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