Surgical navigation system recalled for potential mechanical instability
Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.
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: FDA Class II recall involving a risk-of-harm medical device with potential for mechanical instability during surgical use. No illnesses or injuries have been reported, placing this at the High severity level per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Brainlab AG is recalling the Cirq Arm System 2.0, a surgical navigation device, due to a potential manufacturing error that could cause mechanical instability.
The recalled units were distributed in Texas. All available serial numbers and lot numbers of the product are affected by this recall.
Mechanical instability in surgical navigation equipment poses a risk during medical procedures. Users of the affected devices should immediately discontinue use and contact Brainlab AG or the FDA for further guidance on replacement or repair options.
The recalled product
- Product
- Cirq Arm System 2.0
- Manufacturer
- Brainlab AG
- Affected units
- 1
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)
- 56500 CIRQ ARM SYSTEM 2.0
- GTIN 04056481143961
- All available Serial numbers/lot numbers are affected.
Distribution
Distributed in 1 state:
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