Z-1292-2023 Class II Ongoing
FDA device recall Z-1292-2023 was initiated by Brainlab AG on March 2, 2023 and is designated Class II. Reason for recall: Risk of mechanical instability due to potential manufacturing error of the device The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- March 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Cirq Arm System 2.0
Reason for Recall
Risk of mechanical instability due to potential manufacturing error of the device
Distribution Pattern
Texas
Code Information
56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.