Z-2405-2012Class II

Precise Digital Accelerator Delivery of radiation to defined target volumes

Name: Z-2405-2012 Precise Digital Accelerator Delivery of radiation to defined target volumes
Creator: Elekta, Inc.
Published: 2012-08-06
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-08-06 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Precise Digital Accelerator Delivery of radiation to defined target volumes on 2012-08-06. FDA classified it as Class II and gives the reason as "There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2405-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2012-09-19
Terminated: 2014-10-08
Recalling firm: Elekta Limited
Product: Precise Digital Accelerator Delivery of radiation to defined target volumes
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta sent an Important Field Safety Notice dated August, 2012 to inform users that inspection and possibly bolt replacement needs to be carried out. Users should return the signed acknowledgement to Elketa, and an inspection should be carried out under FCO20002103053. For questions customers should call +44(0)1293 654200. For questions regarding this recall call 770-300-9725.
Quantity in commerce: 110
Distribution: Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto
Product codes and lots: 151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)