—#66636

Product

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 product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993425
Affected lot / code info: All Serial Numbers up to Serial Number: 3532

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2007-07-27
Posted by FDA: 2008-02-19
Terminated: 2011-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.