RobotRisk › Noah Medical › 09 Mar 2024
FDA Class II recall: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller)
S3 · 09 Mar 2024 · Noah Medical
Record
| Company | Noah Medical |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 09 Mar 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 | Galaxy System REF GAL-001 (specifically GAL-019, Wired Contr |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class II, recall Z-1734-2024): Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 09 Mar 2024 | FDA Class II recall: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) | openFDA enforcement | openFDA enforcement |
Noah Medical other incidents timeline
Medical robotics context
recall context
Noah Medical industry position
Related incidents
Other Noah Medical entries
- 12 Sep 2025 - FDA Class II recall: Brand Name: Galaxy System
- 28 Oct 2024 - FDA Class II recall: Galaxy System (GAL-001).
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