Mevatron MD (MD, MDX); 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.

This recall has been terminated (originally issued January 17, 2012).

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: December 1, 2011
Posted: January 17, 2012
Terminated: December 2, 2013
Recall Number: Z-0789-2012
Quantity: 327 Active Devices - all models
Firm Location: Concord, CA
Official Source: View on FDA website ↗

Reason for Recall

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

Distribution

Worldwide Distribution - USA (nationwide)

Lot / Code Info

Part number 8319808, all units

Root Cause

Nonconforming Material/Component

Action Taken

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.