FDA recall Z-2925-2020

Brainlab AG · Class II · device

Product

Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)

Reason for recall

Holding force of the Positioning Arm can be reduced by prolonged non-use.

Distribution

USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom

Key facts

Status
Terminated
Initiation date
2020-08-20
Report date
2020-09-09
Termination date
2021-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2925-2020