Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0852-2008

Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No...

Siemens Medical Solutions USA, Inc. / initiated 2007-07-27 / Terminated / root cause: design

Siemens Medical Solutions USA, Inc began a recall of Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005... on . The reason FDA records is "Door Hinge failures; loose or falling off (Stationary Structure Doors)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0852-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
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
Product code
IYE Accelerator, Linear, Medical
Reason for recall
Door Hinge failures; loose or falling off (Stationary Structure Doors)
Root cause tag
design
FDA root cause
Component design/selection
Action
Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Quantity in commerce
1,284 total for recalls Z-0850-0852-2008
Distribution
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.
Product codes and lots
All Serial Numbers