Recall Z-1585-2016— Shimadzu Medical Systems

Name: FDA recall Z-1585-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2016-03-31, terminated 2017-01-02. FDA's recall record names no specific 510(k) clearance for this event. Product: X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography. Reason: Report of unintentional movement of table to reverse tilting..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Terminated: 2017-01-02
Firm location: Torrance, CA, United States

Product description

X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

Reason for recall

Report of unintentional movement of table to reverse tilting.

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