Z-0998-2026Class II

The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient...

Name: Z-0998-2026 The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient...
Creator: Vision RT Ltd
Published: 2025-08-27
License: https://open.fda.gov/license/

Vision Rt Inc / initiated 2025-08-27 / Open, Classified / root cause: labeling and UDI

FDA source

Vision RT Ltd began a 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 on 2025-08-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0998-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-27
Posted: 2026-01-07
Recalling firm: Vision Rt Inc
Product: The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Product code: IWE Monitor, Patient Position, Light-Beam
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).
Root cause tag: labeling and UDI
FDA 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 in commerce: 56
Distribution: U.S. and OUS
Product codes and lots: Part Number V000629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0998-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0998-2026	Class II	Ongoing	FDA Mandated	2026-01-14	2026-01-06

Product code IWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)