How many recalls does Elekta, Inc. have?

Recalert has 58 U.S. recalls on record for Elekta, Inc., published between July 18, 2012 and July 15, 2026.

Which agencies have handled Elekta, Inc. recalls?

Elekta, Inc. appears as the recalling firm in recalls from: FDA (58).

Elekta, Inc.: 58 recalls on record

Recalls filed with 1 agency: FDA (58).

First recall on record: July 18, 2012. Most recent: July 15, 2026.

Risk classification: Class II: 58

Most recent recalls

Date	Agency	Product	Recall number
June 25, 2014	FDA	Synergy XVI Intended for radiation therapy treatment.Z-1724-2014	Z-1724-2014
June 25, 2014	FDA	iGUIDE System Product Usage: The intended use of the device is the control of accurat…Z-1807-2014	Z-1807-2014
June 25, 2014	FDA	MOSAIQ, an oncology information system used to manage workflows for treatment planning an…Z-1800-2014	Z-1800-2014
May 7, 2014	FDA	HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation …Z-1514-2014	Z-1514-2014
April 9, 2014	FDA	Integrity 1.1. Integrity is the interface and control software for the Elekta range of…Z-1322-2014	Z-1322-2014
March 26, 2014	FDA	SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatm…Z-1064-2014	Z-1064-2014
March 19, 2014	FDA	XiO RPT System The XiO RTP System is used to create treatment plans for any cancer pat…Z-1197-2014	Z-1197-2014
March 12, 2014	FDA	Integrity. Version 1.1 of the Integrity interface and control software for the Elekta ra…Z-1083-2014	Z-1083-2014
March 12, 2014	FDA	Agility. Version 3.1 of the Integrity interface and control software for the Elekta rang…Z-1085-2014	Z-1085-2014
March 12, 2014	FDA	All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or…Z-1065-2014	Z-1065-2014
March 12, 2014	FDA	RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is …Z-1081-2014	Z-1081-2014
March 12, 2014	FDA	Agility. Version 3.0 of the Integrity interface and control software for the Elekta rang…Z-1084-2014	Z-1084-2014
March 12, 2014	FDA	Desktop Pro TM linear accelerator control software intended to assist a licensed practiti…Z-1082-2014	Z-1082-2014
March 5, 2014	FDA	DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators…Z-0978-2014	Z-0978-2014
February 26, 2014	FDA	Synergy XVI XVI can incorrectly calculate the target position of the treatment table, …Z-1059-2014	Z-1059-2014
February 26, 2014	FDA	Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatmen…Z-1061-2014	Z-1061-2014
February 12, 2014	FDA	XiO RTP System. Used to create treatment plans for any cancer patient for whom externa…Z-0928-2014	Z-0928-2014
January 29, 2014	FDA	XiO RTP System The XiO RTP System is used to create treatment plans for any cancer pat…Z-0780-2014	Z-0780-2014
November 13, 2013	FDA	Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device…Z-0138-2014	Z-0138-2014
October 2, 2013	FDA	Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment pl…Z-2277-2013	Z-2277-2013
October 2, 2013	FDA	Monaco RTP System Radiation treatment planningZ-2276-2013	Z-2276-2013
September 11, 2013	FDA	DMLC IV-ERGO - Beam shaping block for Radiation Therapy.Z-2157-2013	Z-2157-2013
June 5, 2013	FDA	Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use wh…Z-1402-2013	Z-1402-2013
April 17, 2013	FDA	Precise Treatment Table. To be used as part of radiation therapy treatment process.Z-1072-2013	Z-1072-2013
March 20, 2013	FDA	Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4…Z-0931-2013	Z-0931-2013

Questions about this company

How many recalls does Elekta, Inc. have?: Recalert has 58 U.S. recalls on record for Elekta, Inc., published between July 18, 2012 and July 15, 2026.
Which agencies have handled Elekta, Inc. recalls?: Elekta, Inc. appears as the recalling firm in recalls from: FDA (58).

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Elekta, Inc.: 58 recalls on record

Most recent recalls

Questions about this company

Do you carry products from Elekta, Inc.? Check your whole catalog free against 80,000+ recalls.

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