CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
Cirq Arm System recalled by Brainlab AG
Brainlab is recalling Cirq Arm System, distributed in District of Columbia, Illinois, Ohio. The recall was initiated on 20 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2925-2020
- FDA event ID
- 86272
- Recalling firm
- Brainlab, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2020
- FDA classified
- 29 Aug 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2020 | Recall initiated by company | |
| 29 Aug 2020 | Classified by FDA | +9 days |
| 9 Sep 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Holding force of the Positioning Arm can be reduced by prolonged non-use.
Product as listed by the FDA
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)
Where it was distributed
USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
Questions about this recall
Why was it recalled?
Holding force of the Positioning Arm can be reduced by prolonged non-use.
Which lots are affected?
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
Where was it sold?
USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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