—#47300

Product

LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K981313
Affected lot / code info: Site Numbers: 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118

Why it was recalled

Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.

Root cause (FDA determination)

Software design

Action the firm took

The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland

Timeline

Recall initiated: 2006-07-07
Posted by FDA: 2006-08-11
Terminated: 2008-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.