FDA Device recall Z-0998-2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement by Vision Rt, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0998-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-27 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Vision Rt |
| Distribution | n/a |
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).
Identifiers
| code_info | Part Number V000629 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2026%22
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