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Terminated

Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

FDA Recall Z-0251-2016 · Posted None

Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeJAA
Date Initiated2015-09-30
Date Terminated2016-09-12
Product Quantity26 units total (4 units in US)

Reason for Recall

The C-arm may interfere with the table top under certain circumstances.

Firm Action

An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963888C-ARM TABLE IVS-100Shimadzu Medical Systems · 1996-12-18

Official Source

View FDA Recall →

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

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