FDAClass IISeptember 9, 2020

Cirq Arm System recall

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)

Why was Cirq Arm System recalled?

Holding force of the Positioning Arm can be reduced by prolonged non-use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

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)
Recalling firm
Brainlab AG
Quantity
21 arms
Distribution
USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
Recall date
September 9, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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