Recall Z-2925-2020— Brainlab AG

Name: FDA recall Z-2925-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-20

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2020-08-20, terminated 2021-05-13. It names one FDA 510(k) clearance: K183605. 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). Reason: Holding force of the Positioning Arm can be reduced by prolonged non-use..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2020-08-20
Terminated: 2021-05-13
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K183605 — Spine & Trauma NavigationBrainlab AG·cleared 2019-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.