Recall Z-2925-2020
Brainlab AG · initiated August 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: 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
Reason for recall
Holding force of the Positioning Arm can be reduced by prolonged non-use.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-2925-2020
- Initiated
- August 20, 2020
- Terminated
- May 13, 2021
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Quantity
- 21 arms
- Distribution
- USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
- Recalling firm
- Brainlab AG, Munich