RobotRisk › Auris Health (J&J MedTech) › 02 Aug 2024
FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.
S3 · 02 Aug 2024 · Auris Health (J&J MedTech)
Record
| Company | Auris Health (J&J MedTech) |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 02 Aug 2024 (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 (Endoscopy), REF: MON-000005-01, MON-000005 |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class II, recall Z-0051-2025): Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 02 Aug 2024 | FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. | 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
- 18 Oct 2023 - FDA Class II recall: Monarch Platform
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