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Recall Observatory FDA recall evidence

Device product

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

Z-0251-2016

September 30, 2015

Class II

Product summary

Firm
Shimadzu Medical Systems
Event
Event 72376
Status
Terminated
Classification
Class II
Quantity
26 units total (4 units in US)
Official record key
device-enforcement:Z-0251-2016

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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