Recall Z-0746-2012 ยท IWZ Film, Radiographic
Carestream Health, Inc.
DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. General purpose radiography.
| Date | Jan 13, 2012 (initiated Dec 20, 2011) |
| Status | Terminated |
| Reason | Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density. |
| Root cause | Nonconforming Material/Component |
| Action | Carestream Health Inc. sent an "URGENT PRODUCT REMOVAL" letter dated December 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to identify, segregate, and return any affected product to the firm. A Product Information Form was attached to the letter for customers to complete and return via fax to 541-831-7101. Contact Technical Support at 1-800-328-2910 for questions regarding this notice. |
| Quantity | 24 cartridges |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of Alabama, Florida, Georgia, and Tennessee and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.