Brainlab Cirq Arm System Recalled for Reduced Holding Force
Brainlab AG is recalling 21 Cirq Arm Systems because prolonged non-use can reduce the holding force of the positioning arm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (reduced holding force) that poses a risk of harm, fitting the criteria for a High severity score.
Plain-English summary
Brainlab AG is recalling 21 units of the Cirq Arm System, specifically models SBS 1.3.2 and SBS 1.4. The recall involves specific serial numbers for Article Numbers 56000-01B and 56000-01C.
The recall is being issued because the holding force of the Positioning Arm can be reduced by prolonged non-use. This defect may affect the stability of the arm during use.
The affected units were distributed in the United States (DC, OH, IL) and internationally in Bulgaria, France, Germany, and the United Kingdom. Users should contact Brainlab AG for further instructions on how to address this issue.
The recalled product
- 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)
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Article Number: 56000-01B
- Description: CIRQ ARM SYSTEM 1.3.2
- Description:CIRQ ARM SYSTEM 1.4
Distribution
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