| Class 2 Device Recall Del Medical VS300 radiographic Cassette Holder or Wall Stand | |
Date Initiated by Firm | December 03, 2015 |
Create Date | February 05, 2016 |
Recall Status1 |
Terminated 3 on January 26, 2018 |
Recall Number | Z-0762-2016 |
Recall Event ID |
72798 |
Product Classification |
Holder, radiographic cassette, wall-mounted - Product Code IXY
|
Product | VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department. |
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 |
Recalling Firm/ Manufacturer |
Del Medical, Inc. 241 Covington Dr Bloomingdale IL 60108-3109
|
For Additional Information Contact | Mr. Tony Bavuso 847-288-7902 |
Manufacturer Reason for Recall | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. |
FDA Determined Cause 2 | Employee error |
Action | The firm sent an email followed by a certified undated letter entitled Safety Related Notification- Field Corrective Action VS-200 and VS-300 Wallstands notifying customers of the recall and actions to be taken.
To prevent the possible interruption of service, Del Medical has prepared a service kit which must be installed at the next available opportunity.
Del Medical is sending service kits to affected customers. Included within the package will be needed components and, a fixture which will facilitate a one person job. The firm expects the procedure to occupy one hour or, less. Also included with each kit will be an acknowledgement form which is intended to document the fix. The form, along with the original parts are to be returned to Del Medical upon completion of the activity to the following address:
Del Medical 241 Covington Drive Bloomingdale, Illinois 60108
Attention: Bill Kostecki 1-847-288-7000 |
Quantity in Commerce | 4000 |
Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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