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Pro-Med Instruments Gmbh recalls DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Recalled September 26, 2018 · FDA recall Z-2970-2018 · Pro-Med Instruments
Hazard
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. · FDA Class I
Units
30 units
Sold at
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
Description
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.
Product
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Manufacturer(s)
Pro-Med Instruments Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →