Z-1088-2015Class II

Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic...

Name: Z-1088-2015 Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic...
Creator: Elekta, Inc.
Published: 2015-01-07
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-01-07 / Terminated

FDA source

Elekta, Inc. began a recall of Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical... on 2015-01-07. FDA classified it as Class II and gives the reason as "Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1088-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Posted: 2015-02-10
Terminated: 2016-04-14
Recalling firm: Elekta Limited
Product: Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
FDA root cause: Other
Action: Elekta sent an Urgent Important Field Safety Notice on January 7, 2015, to all affected customers. Elekta recommended that customers replace the M20 x 50 MM bolts marked 'OF' on the gantry counterbalance frame immediately. The digital linear accelerator must not be used until these 'OF' bolts are replaced. Elekta recommended that customers put the machine in a parked position at 0, and attach the gantry locking straps. A Modification kit will be available as soon as possible which contains the correct bolts. Customers were instructed to complete the Important Field Safety Notice Acknowledgement form and return to their local Elekta Office or Representative. Customers with questions were instructed to contact their local Elekta representative. For questions regarding this recall call 404-993-5886.
Quantity in commerce: 46
Distribution: Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.
Product codes and lots: 153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1088-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1088-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code IYE

K051932Class IIElekta Synergy; Elekta Synergy S and Xvir3.5Elekta, Inc. / cleared 2005-08-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)