FDA-Device2018-09-26Class I
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments Gmbh
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.
Sold states
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
Affected count
31 units
Manufactured in
Botzinger Str. 38, N/A, Freiburg Im Breisgau, N/A, Germany
Products
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2972-2018Don't want to check this manually?
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