The Recall Desk
HighFDA (Devices)·Z-0448-2024·Announced 2023-12-13

Monarch Platform bronchoscope recalled for potential software image inversion

AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.

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 medical device recall for a potential software defect affecting critical surgical visualization. The hazard is identified but the source does not report any confirmed incidents or injuries.

Plain-English summary

The Monarch Platform is a surgical robotic system manufactured by AURIS Health Inc. for use in minimally invasive respiratory procedures. The device includes a virtual bronchoscope for visualization during surgery.

A software issue may cause the bronchoscope view to appear flipped or inverted during operation. This could impair the surgeon's ability to visualize the surgical field accurately and guide the instrument properly during procedures.

This recall affects 110 units of the Monarch Platform distributed across 34 U.S. states.

The recalled product

Product
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Manufacturer
AURIS HEALTH INC
Category
Medical Device — Surgical / Robotic
Hazard
  • image-inversion
  • software-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 (1)

  • Software Version 2.2.4

Distribution

Distributed in 34 states:

  • AK
  • AL
  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • IL
  • IN
  • KY
  • MA
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NY
  • OH
  • OR
  • PA
  • SC
  • SD
  • TN
  • TX
  • WI
  • WV

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