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Terminated

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

FDA Recall Z-1585-2016 · Posted 2016-04-28

Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeIXR
Date Initiated2016-03-31
Date Terminated2017-01-02
Product Quantity185 units

Reason for Recall

Report of unintentional movement of table to reverse tilting.

Firm Action

Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers on April 8, 2016. Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray Diagnostic Table. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contacted Shimadzu National Technical Support at (800) 228-1429. Shimadzu will send out an updated customer notification letter to inform customers that the liquid penetration may cause an electrical short circuit, causing the table to unintentionally tilt in reverse. If this unintentional reverse tilting occurs, there is a potential risk of injury to the patient and/or the user. For questions regarding this recall call 310-217-8855, ext 139.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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