Z-1723-2011

Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a...

Name: Z-1723-2011 Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a...
Creator: Elekta, Inc.
Published: 2010-10-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-10-25 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner on 2010-10-25. The reason FDA records is "If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1723-2011
Status: Terminated
Initiated: 2010-10-25
Posted: 2011-03-22
Terminated: 2011-05-24
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment data is never received by the R&V system.
FDA root cause: Other
Action: Important Notice A341 titled "Mandatory Upgrade Desktop Pro R7.01 Service Pack and Cancelled Notices" dated January 26, 2011, is in distribution to all affected customers. Field Change Order 20000501011, "Service Pack 2 upgrade to Desktop Pro R7.01 Service Pack 1", dated October 25, 2010 will be utilized by Elekta Service personnel to upgrade the Desktop Pro to include Service Pack 2. The Important Notice letter instructed customers to file the letter in the Important Notice section of the appropriate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their treatment control system. If it is not installed, customers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and should be removed from the User Manual. Customers should direct their questions to their local Elekta representative.
Quantity in commerce: 13 units
Distribution: Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.
Product codes and lots: Serial Numbers 152019, 152117, 151566, 152271, 151942, 152116, 151141, 151885, 152211, 152214, 152158, 151628, and 152207.

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)