Bronchoscopy robots recalled over arms that may move toward patient-left

Plain-English summary

The MONARCH Platform, Bronchoscopy, catalog numbers MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB and MON-000008 with software, is being recalled by Auris Health, Inc. The record describes the device as being for bronchoscopic visualization and patient airway access.

The record states the device has a software issue: if the application restarts after patient-side selection but prior to bronchoscope loading, the application will re-initialize to the patient-left position. If the right position was previously selected, the record states this may lead to unanticipated robotic arm positioning toward patient-left, which may result in contact with the patient or the endotracheal tube.

The record lists 173 units, covering software versions 2.2.2, 2.2.3, 2.2.4, 2.2.5 and 4.1.1, with UDI-DI codes recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Auris Health's instructions.

The recalled product

Product

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

Manufacturer

Auris Health, Inc

Category

Medical Device — Surgical robotics

Hazard

• software-fault
• unanticipated-movement
• bronchoscopy
• patient-contact

Affected units

173

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Distribution

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