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Recall Observatory FDA recall evidence

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)

Z-2925-2020

August 20, 2020

Class II

Product summary

Firm
Brainlab AG
Event
Event 86272
Status
Terminated
Classification
Class II
Quantity
21 arms
Official record key
device-enforcement:Z-2925-2020

Official wording

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

Code information: Article Number: 56000-01B, Description: CIRQ ARM SYSTEM 1.3.2, Serial numbers: 20100132017 20100132019 20100132020 20100132022 20100132023 20100132026 20100132028 20100132030 20100132031 20100132033 20100132035 20100132036 20100132037 20100132038 20100132039 Article Number: 56000-01C, Description:CIRQ ARM SYSTEM 1.4, Serial numbers: 20100140052 20100140053 20100140054 20100140055 20100140056 20100140057

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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