Z-1238-2015Class II

Elekta Precise Treatment Table

Name: Z-1238-2015 Elekta Precise Treatment Table
Creator: Elekta, Inc.
Published: 2015-01-29
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-01-29 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta Precise Treatment Table on 2015-01-29. FDA classified it as Class II and gives the reason as "It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1238-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-29
Posted: 2015-03-19
Terminated: 2021-11-05
Recalling firm: Elekta Limited
Product: Elekta Precise Treatment Table
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.
FDA root cause: Radiation Control for Health and Safety Act
Action: Planned Action by Elekta: 1. Notifications have been sent out. The notification informs users of the possibility treatment table position errors might occur if there is a maintenance error when replacing a potentiometer. The notification recommends establishing a procedure to verify the accuracy of the treatment table position as shown by the treatment room monitor which is performed as part of the daily machine checks. An example procedure is provided. 2. Elekta will establish a procedure service engineers will follow after maintenance involving the relevant potentiometers to ensure proper installation. The procedure will be taught using a video which includes a step by step guide to the correct methodology for installation of the potentiometer assembly, a description of the impact for not installing correctly, and a guide to the new verification of correct installation procedure. The video will be distributed through Elektas learning management system (LMS). The LMS maintains a record of service engineers who successfully complete the training. 3. Elekta will implement an engineering change to the potentiometer assembly which applies to the manufacture of all new Precise Treatment Tables. This change will eliminate the potential for incorrect installation and will prevent a loose grub screw from causing backlash. This change is expected to consist of a 'D' shaped bore that cannot spin on the shaft of the potentiometer. All actions associated with this correction, including service engineer training, will be completed by June 2015. For further questions please call (770) 300-9725.
Quantity in commerce: 529 US 2951 Worldwide
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland and Syria.
Product codes and lots: Precise Treatment Table Serial Numbers: (124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125966-1256453, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,123318-330, 126338-126373, 126375-397, 126400-133999, 213000+)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1238-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1238-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-19

Product code JAI

K983678Class IIElekta Oncology Systems Precise Treatment TableElekta Instruments, Inc. / cleared 1999-01-15

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)