—#97838

Product

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051932
Affected lot / code info: Serial Numbers 152019, 152117, 151566, 152271, 151942, 152116, 151141, 151885, 152211, 152214, 152158, 151628, and 152207.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.

Timeline

Recall initiated: 2010-10-25
Posted by FDA: 2011-03-22
Terminated: 2011-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.