FDA DevicesClass II
The AlignRT InBore system contains six Class 1 lasers which enables the system s...
Published: January 14, 2026Recall ID: Z-0998-2026Category: devicesCountry: US
Reason for Recall / Hazard
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Product Description & Identification
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Additional Source Details
| Field | Value |
|---|---|
| City | London |
| Event id | 98236 |
| Address 1 | Dove House |
| Address 2 | Arcadia Avenue |
| Code info | Part Number V000629 |
| Postal code | N/A |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 56 |
| Reason for recall | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20250827 |
| Center classification date | 20260106 |
Overview
- Recalling FirmVision RT Ltd
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. and OUS