Recall archive / FDA device enforcement
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s posit... — FDA record Z-0998-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Reason
- 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).
- Classification
- Class II
- Recalling firm
- Vision RT Ltd
- Quantity
- 56
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0998-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number V000629 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. and OUS
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 14, 2026
- Recall initiation date
- Aug 27, 2025
- Center classification date
- Jan 6, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.