The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position
Summary
The FDA issued a Class II for The AlignRT InBore system contains six Class 1 lasers which enables the system s by Vision RT Ltd. Reason: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers .
Details
Source
Device Recall
External ID
Z-0998-2026
Action Date
2026-01-14
Status
Ongoing
Category
device
Product Description
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Lot/Code Info: Part Number V000629
Quantity Affected: 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).
Distribution
U.S. and OUS
Type: FDA Mandated
Recall Initiated: 2025-08-27
Company
London
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 98 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vision RT Ltd has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vision RT Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vision RT Ltd have FDA actions?
Vision RT Ltd has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0998-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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