—#69072

Product

Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K862339
Affected lot / code info: Serial numbers: 3061 3986 2469 2476 2443 2455 2549 2719 2728 2772 2795 2821 2925 2999 3056 3083 3088 3169 3282 3325 3429 3432 3472 3538 3555 3563 3593 3633 3637 3682 3685 3726 3971 4007 5055 3923 2707 3321, and 2449

Why it was recalled

Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.

Timeline

Recall initiated: 2007-12-10
Posted by FDA: 2008-09-29
Terminated: 2011-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.