The Recall Desk
HighFDA (Devices)·Z-1292-2023·Announced 2023-04-05

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.

What this means for you

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
Category
Medical Device — Surgical Navigation
Hazard
  • mechanical-instability
  • manufacturing-defect

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

Distribution scope not specified by the agency.

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