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Recall Observatory FDA recall evidence

Device product

VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

Z-0762-2016

December 03, 2015

Class II

Product summary

Firm
Del Medical, Inc.
Event
Event 72798
Status
Terminated
Classification
Class II
Quantity
4000
Official record key
device-enforcement:Z-0762-2016

Official wording

Reason: The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.

Code information: Product # Serial # 110-5124G1 , 00019-0114 110-5124G1 , 00020-0114 110-5124G1 , 00092-0114 110-5124G1 , 00551-0314 110-5124G1 , 00512-0214 110-5124G1 , 00447-0214 110-5124G1 , 00016-0114 110-5124G1 , 00554-0314 110-5124G1 , 00094-0114 110-5124G1 , 00256-0214 110-5124G1 , 00741-0314 110-5124G1 , 00446-0214 110-5124G1 , 00017-0114 110-5124G1 , 00093-0114 110-5124G1 , 00236-0114 110-5124G1 , 00814-0414 110-5124G1 , 00815-0414 110-5124G1 , 00340-0214 110-5124G3 , 00995-0414 110-5124G1 , 00338-0214 110-5124G1 , 00552-0314 110-5124G1 , 00253-0214 110-5124G1 , 00445-0214 110-5124G1 , 00254-0214 110-5124G1 , 00095-0114 110-5124G1 , 00670-0314 110-5124G1 , 00252-0214 110-5124G1 , 00018-0114 110-5124G1 , 00669-0314 110-5124G1 , 00339-0214 110-5124G1 , 00444-0214 110-5124G1 , 00255-0214

Distribution pattern: Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.