Recall Z-0762-2016 ยท IXY Holder, Radiographic Cassette, Wall-Mounted
Del Medical, Inc.
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
| Date | Dec 3, 2015 |
| Status | Terminated |
| Reason | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. |
| 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 includ |
| Quantity | 4000 |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.