CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report

The AlignRT InBore system contains six Class 1 lasers which recalled

Vision RT is recalling The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras. The recall was initiated on 27 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number V000629

Quantity recalled56

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0998-2026
FDA event ID: 98236
Recalling firm: Vision RT, London
Classification: Class II
Status: Ongoing
Recall initiated: 27 Aug 2025
FDA classified: 6 Jan 2026
Reported: 14 Jan 2026
Type: FDA Mandated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Aug 2025	Recall initiated by company
6 Jan 2026	Classified by FDA	+132 days
14 Jan 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

U.S. and OUS

Questions about this recall

Is The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras recalled?

Yes. Vision RT recalled The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras on 27 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-0998-2026.

Why was it recalled?

Which lots are affected?

Part Number V000629

Where was it sold?

U.S. and OUS

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Vision RT

All 6

Reported	Class	Recall	Company	Reason	Where
10 Oct 2018Device	CLASS II	Integrated Gate Controller PCB recalled by Vision RT	Vision RT	Other	Nationwide
31 Aug 2016Device	CLASS II	AlignRT¿ Plus [private label-OSMS] K123371 recalled by Vision RT	Vision RT	Other
31 Aug 2016Device	CLASS II	TrueBeam¿ Radiotherapy Delivery System recalled by Vision RT	Vision RT	Other
14 Jan 2015Device	CLASS II	AlignRT is a video-based three-dimensional recalled by Vision Rt	Vision Rt	Device Malfunction	Nationwide
3 Dec 2014Device	CLASS II	AlignRT- Intended for prescription use recalled by Vision Rt	Vision Rt	Device Malfunction	Nationwide

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