Recall Z-0844-2014 ยท KPR System, X-Ray, Stationary
Carestream Health, Inc.
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
| Date | Jan 27, 2014 (initiated Dec 26, 2013) |
| Status | Terminated |
| Reason | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of det |
| Quantity | 164 units Total (42 domestically & 122 internationally) |
| Distribution | worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Swed |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 Eastman Kodak Company, Jun 1, 2005 |