Recall archive / FDA device enforcement
Cirq Arm System 2.0 — FDA record Z-1292-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cirq Arm System 2.0
- Reason
- Risk of mechanical instability due to potential manufacturing error of the device
- Classification
- Class II
- Recalling firm
- Brainlab AG
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1292-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Texas
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Mar 2, 2023
- Center classification date
- Mar 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.