Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0762-2016Class II

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

Del Medical, Inc. / initiated 2015-12-03 / Terminated / root cause: manufacturing process

Del Medical, Inc. began a recall of VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department on . FDA classified it as Class II and gives the reason as "The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0762-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Del Medical, Inc.
Product
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
Product code
IXY Holder, Radiographic Cassette, Wall-Mounted
Reason for recall
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0762-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0761-2016Class IITerminatedVoluntary: Firm initiated
Z-0762-2016Class IITerminatedVoluntary: Firm initiated