Recall Z-2925-2020 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab AG
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)
| Date | Aug 20, 2020 |
| Status | Terminated |
| Reason | Holding force of the Positioning Arm can be reduced by prolonged non-use. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 21 arms |
| Distribution | USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183605 | Spine & Trauma Navigation Brainlab AG, Aug 29, 2019 |