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Terminated

Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA

FDA Recall Z-0850-2008 · 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.

K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26

Official Source

View FDA Recall →

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

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