FDA Medical Device Recalls (openFDA)
Vision RT Ltd: The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Recall number
- Z-0998-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2025-08-27
- Posted
- 2026-01-07
- Terminated
- not on file
- 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).
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Vision 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
- 56
- Distribution
- U.S. and OUS
- Lot, serial or model codes
- Part Number V000629
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWE
- Firm FEI
- 3004832819
- Firm city
- London
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28