FDA recall Z-2971-2018

Product

DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-07-05

Report date

2018-09-26

Termination date

2020-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Freiburg Im Breisgau, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2018