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Terminated

Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron M 7400, Part No.: 5694153; Mevatron M 7445, Part No.: 5694203; Mevatron M 6300, Part No.: 8317000; Mevatron M 6740, Part No.: 8319758; Mevatron MD, Part No.: 8319808; Mevatron ME, Part No.: 8490005; Mevatron MDX, Part No.: 8496200; Mevatron M2 6300, Part No.: 9401316; Mevatron M-2 6700, Part No.: 9401407; Mevatron M2 6740, Part No.: 9401506; Mevatron MD2, Part No.: 09401654; and Mevatron MDX-2, Part No.: 9401746 Siemens Medical Solutions USA, Inc., Concord, CA

FDA Recall Z-0852-2008 · Posted 2008-02-19

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-07-27
Date Terminated2011-04-29
Product Quantity1,284 total for recalls Z-0850-0852-2008

Reason for Recall

Door Hinge failures; loose or falling off (Stationary Structure Doors)

Firm Action

Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.

Root Cause

Component design/selection

Distribution Pattern

Worldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Kansas, Mississippi, Rhode Island, Washington, South Carolina, Maryland, New Hampshire, Maine, Arkansas, Idaho, Missouri, Louisiana, Oklahoma, North Dakota, Minnesota, Massachusetts, and The District of Columbia and countries of Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882729MEVATRON, M 2 CLASSSiemens Medical Laboratories, Inc. · 1988-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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