Pro-Med Instruments Gmbh recalls DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

Recall date

July 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2970-2018

FDA classification

Class I

Brand / firm

Pro-Med Instruments Gmbh

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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