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Terminated

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

FDA Recall Z-0762-2016 · Posted None

Recalling FirmDel Medical, Inc.
Recall StatusTerminated
Product CodeIXY
Date Initiated2015-12-03
Date Terminated2018-01-26
Product Quantity4000

Reason for Recall

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

Firm 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

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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