RAYSEARCH LABORATORIES AB: 41 recalls on record

Recalls filed with 1 agency: FDA (41).

First recall on record: September 12, 2012. Most recent: July 8, 2026.

Risk classification: Class II: 41

Most recent recalls

DateAgencyProduct
June 17, 2020FDARayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy …Z-2340-2020
March 18, 2020FDARayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatmen…Z-1465-2020
March 18, 2020FDARayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatmen…Z-1466-2020
March 18, 2020FDARayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatme…Z-1463-2020
July 10, 2019FDARayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation …Z-1930-2019
April 19, 2017FDARadiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a softwar…Z-1815-2017
December 14, 2016FDARayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product …Z-0721-2017
June 25, 2014FDARayStation software version 4.0.3.4 RayStation is a software system designed for treat…Z-1806-2014
April 30, 2014FDARaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. …Z-1481-2014
April 9, 2014FDARaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone softwareZ-1308-2014
April 9, 2014FDARayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a s…Z-1307-2014
November 20, 2013FDARay Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0Z-0281-2014
June 5, 2013FDARayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICA…Z-1419-2013
October 3, 2012FDASharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing na…Z-2444-2012
September 26, 2012FDAThe product affected by this notice is sold under the trade name TomoTherapy SharePlan 1…Z-2378-2012
September 12, 2012FDABrand name: RayStation. Generic name: Treatment Planning System. Software version and …Z-2324-2012

Questions about this company

How many recalls does RAYSEARCH LABORATORIES AB have?
Recalert has 41 U.S. recalls on record for RAYSEARCH LABORATORIES AB, published between September 12, 2012 and July 8, 2026.
Which agencies have handled RAYSEARCH LABORATORIES AB recalls?
RAYSEARCH LABORATORIES AB appears as the recalling firm in recalls from: FDA (41).

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