Z-0251-2016 Class II Terminated

Recalled by Shimadzu Medical Systems — Torrance, CA

FDA device recall Z-0251-2016 was initiated by Shimadzu Medical Systems on September 30, 2015 and is designated Class II. Reason for recall: The C-arm may interfere with the table top under certain circumstances. The recall status is terminated (terminated September 12, 2016). Affected quantity: 26 units total (4 units in US).

Recall Details

Product Type
Devices
Report Date
November 18, 2015
Initiation Date
September 30, 2015
Termination Date
September 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26 units total (4 units in US)

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301 0261H26201 0161H29501 0161H29901 0261H26101 0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001 0161H27402 0161H27201