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

FDA Recall #Z-0762-2016 — Class II — December 3, 2015

Recall #Z-0762-2016 Date: December 3, 2015 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Del Medical, Inc. — Bloomingdale, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4000

Distribution

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

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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