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U.S. Department of Health and Human Services

Class 2 Device Recall AlignRT InBore, Part Number V000629

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 Class 2 Device Recall AlignRT InBore, Part Number V000629see related information
Date Initiated by FirmAugust 27, 2025
Date PostedJanuary 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0998-2026
Recall Event ID 98236
Product Classification Monitor, patient position, light-beam - Product Code IWE
ProductThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Code Information Part Number V000629
Recalling Firm/
Manufacturer		 Vision RT Ltd
Dove House
Arcadia Avenue
London United Kingdom
Manufacturer 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).
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionVision RT wrote to inform customers of an omission that they have identified in the Instructions for Use for AlignRT InBore systems. This notification contained information for users of AlignRT InBore systems on the content omitted and how to access the corrected Instructions for Use.
Quantity in Commerce56
DistributionU.S. and OUS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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