Vision RT Ltd Recall: The AlignRT InBore system contains six Class 1 lasers which enables
Vision RT Ltd Recall: The AlignRT InBore system contains six Class 1 lasers which enables is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Vision RT Ltd; Product: The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and
| Recalling firm | Vision RT Ltd |
|---|---|
| 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 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | U.S. and OUS |
| Recall initiated | 20250827 |
| Recall number | Z-0998-2026 |
| Category | device |
| Country | United Kingdom |
$29/mo
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