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Terminated

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)

FDA Recall Z-2925-2020 · Posted None

Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeOLO
Date Initiated2020-08-20
Date Terminated2021-05-13
Product Quantity21 arms

Reason for Recall

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

Firm Action

Brainlab will be distributing the Medineering Field Safety Notice / Product Notification CAPA-17 to the consignees via email. Instruction for user on how to effectively avoid the situation of risk to occur (i.e. how to avoid the described potential risk), please also refer to the Corrective action by the user section of the Medineering Field Safety Notice / Product Notification CAPA-17. 1. Please identify all Positioning Arms with the specified serial numbers 2. Especially when the arm is freestanding and unsupported, ensure that the Positioning Arm is not above the patient or the user. 3. Avoid unfavorable positions of the Positioning Arm. Examples of these can be found in the instructions or use in the payload test section. 4. Check the secure hold after each arm alignment.

Root Cause

Component design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183605Spine & Trauma NavigationBrainlab AG · 2019-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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