CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report

Cirq Arm System recalled by Brainlab AG

Brainlab AG 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

Lot, batch or date codesArticle 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

Quantity recalled21 arms

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 AG, 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: E-Mail
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

District of Columbia Illinois Ohio

Questions about this recall

Is Cirq Arm System recalled?

Yes. Brainlab AG recalled Cirq Arm System on 20 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2925-2020.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Brainlab AG

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Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Origin Data Management recalled by Brainlab AG	Brainlab AG	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab AG	Potency & Assay	TX
22 Mar 2023Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Device Malfunction	Nationwide
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Device Malfunction	20 states
16 Jun 2021Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Processing Deviation	Nationwide

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