CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

AlignRT- Intended for prescription use recalled by Vision Rt

Vision Rt is recalling AlignRT- Intended for prescription use, distributed in California, Minnesota, Texas, Utah. The recall was initiated on 15 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.

Quantity recalled7 (Six Units distribited in the US and One in OUS.)

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-0464-2015
FDA event ID: 69515
Recalling firm: Vision Rt, Columbia, MD
Classification: Class II
Status: Terminated
Recall initiated: 15 Oct 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 Oct 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+41 days
3 Dec 2014	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

Potential failure of AlignRT to assert interlock.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Where it was distributed

Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.

California Minnesota Texas Utah

Questions about this recall

Why was it recalled?

Potential failure of AlignRT to assert interlock.

Which lots are affected?

Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.

Where was it sold?

Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.

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 26 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
14 Jan 2026Device	CLASS II	The AlignRT InBore system contains six Class 1 lasers recalled	Vision RT	Other
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

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide