—#106267

Product

Mevatron M2 6300; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K882729
Affected lot / code info: Part number 9401316, all units

Why it was recalled

Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide)

Timeline

Recall initiated: 2011-12-01
Posted by FDA: 2012-01-17
Terminated: 2013-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.