RobotRisk › Auris Health (J&J MedTech) › 18 Oct 2023
FDA Class II recall: Monarch Platform
S3 · 18 Oct 2023 · Auris Health (J&J MedTech)
Record
| Company | Auris Health (J&J MedTech) |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 18 Oct 2023 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | Monarch Platform |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class II, recall Z-0450-2024): Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 18 Oct 2023 | FDA Class II recall: Monarch Platform | openFDA enforcement | openFDA enforcement |
Auris Health (J&J MedTech) other incidents timeline
Medical robotics context
recall context
Auris Health (J&J MedTech) industry position
Related incidents
Other Auris Health (J&J MedTech) entries
- 21 Jan 2026 - FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
- 02 Aug 2024 - FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.
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