Z-2925-2020Class II

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...

Name: Z-2925-2020 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...
Creator: Brainlab AG
Published: 2020-08-20
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2020-08-20 / Terminated / root cause: design

FDA source

Brainlab AG began a recall of 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) on 2020-08-20. FDA classified it as Class II and gives the reason as "Holding force of the Positioning Arm can be reduced by prolonged non-use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2925-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-20
Posted: 2020-08-29
Terminated: 2021-05-13
Recalling firm: Brainlab, Inc.
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)
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Holding force of the Positioning Arm can be reduced by prolonged non-use.
Root cause tag: design
FDA 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. 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.
Quantity in commerce: 21 arms
Distribution: USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2925-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2925-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-29

Product code OLO

K183605Class IISpine & Trauma NavigationBrainlab AG / cleared 2019-08-29

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)