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U.S. Department of Health and Human Services

Class 2 Device Recall Del Medical VS200 radiographic Cassette Holder or Wall Stand

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  Class 2 Device Recall Del Medical VS200 radiographic Cassette Holder or Wall Stand see related information
Date Initiated by Firm December 03, 2015
Create Date February 05, 2016
Recall Status1 Terminated 3 on January 26, 2018
Recall Number Z-0761-2016
Recall Event ID 72798
Product Classification Holder, radiographic cassette, wall-mounted - Product Code IXY
Product VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
Code Information Product # Serial # 110-5010G1 , 00504-0214 110-5010G1 , 00855-0414 110-5010G1 , 00182-0114 110-5010G1 , 00108-0114 110-5010G1 , 00479-0214 110-5010G1 , 00014-0114 110-5010G1 , 00251-0214 110-5010G1 , 00854-0414 110-5010G1 , 00505-0214 110-5010G1 , 00342-0214 110-5010G1 , 00477-0214 110-5010G1 , 00184-0114 110-5010G1 , 00248-0214 110-5010G1 , 00588-0314 110-5010G1 , 00852-0414 110-5010G1 , 00107-0114 110-5010G1 , 00183-0114 110-5010G1 , 00480-0214 110-5010G1 , 00503-0214 110-5010G1 , 00443-0214 110-5010G1 , 00853-0414 110-5010G1 , 00941-0414 110-5010G1 , 00013-0114 110-5010G1 , 00343-0214 110-5010G1 , 00478-0214 110-5010G1 , 00249-0214 110-5010G1 , 00185-0114 110-5010G1 , 00442-0214 110-5010G1 , 00632-0314 110-5010G1 , 00475-0214 110-5010G1 , 00507-0214 110-5010G1 , 00015-0114 110-5010G1 , 00631-0314 110-5010G1 , 01008-0514 110-5010G1 , 00635-0314 110-5010G1 , 00011-0114 110-5010G1 , 00012-0114 110-5010G1 , 00345-0214 110-5010G1 , 00590-0314 110-5010G1 , 00440-0214 110-5010G1 , 00591-0314 110-5010G1 , 00506-0214 110-5010G1 , 00106-0114 110-5010G1 , 00774-0314 110-5010G1 , 00508-0214 110-5010G1 , 00476-0214 110-5010G1 , 00186-0114 110-5010G1 , 00587-0314 110-5010G1 , 00441-0214 110-5010G1 , 00589-0314 110-5010G1 , 00250-0214 110-5010G1 , 00247-0214 110-5010G1 , 00773-0314 110-5010G1 , 00344-0214 110-5010G3 , 01090-0514 110-5010G3 , 00709-0314 110-5010G3 , 00988-0414 110-5010G3 , 00010-0114 110-5010G4 , 01080-0514 110-5010G4 , 00047-0114 110-5010G4 , 00925-0414 
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
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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