Z-1292-2023Class II

Cirq Arm System 2.0

Name: Z-1292-2023 Cirq Arm System 2.0
Creator: Brainlab AG
Published: 2023-03-02
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2023-03-02 / Open, Classified / root cause: manufacturing process

FDA source

Brainlab AG began a recall of Cirq Arm System 2.0 on 2023-03-02. FDA classified it as Class II and gives the reason as "Risk of mechanical instability due to potential manufacturing error of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1292-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-02
Posted: 2023-03-28
Recalling firm: Brainlab, Inc.
Product: Cirq Arm System 2.0
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Risk of mechanical instability due to potential manufacturing error of the device
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued a URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION to their consignees by email on 03/02/2023. The notice explained the issue, risk of use, and requested the following actions be taken: "1. Do not use Cirq Arm System 2.0 for clinical procedures. 2. Remove Cirq Arm System 2.0 from the OR table (as applicable), following the description given in the applicable User Guide. When lifting Cirq Arm System 2.0, ensure you carry the device only below joint 4 (see picture 1) to prevent user injury from falling parts. 3. Store the device in the corresponding transport and storage case delivered with it and ensure you mark the equipment appropriately to prevent it from being used inadvertently." Brainlab is seeking return of the devices for inspection and repair (if applicable).
Quantity in commerce: 1 unit
Distribution: Texas
Product codes and lots: 56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-28

Product code OLO

K222966Class IICirq Arm System (2.0);Alignment System SpineBrainlab AG / cleared 2022-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)