X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, a

FDA device recall Z-1585-2016 · posted 2016-04-28 · Terminated

Recall details

Recalling firm

Shimadzu Medical Systems

Reason for recall

Report of unintentional movement of table to reverse tilting.

Action taken

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

Status

Terminated

Product code

IXR

Quantity affected

185 units

Distribution

Nationwide Distribution

Date initiated

2016-03-31

Date posted

2016-04-28

Date terminated

2017-01-02

Location

Torrance, CA