Recall Z-0797-2014 ยท IZL System, X-Ray, Mobile
Carestream Health, Inc.
DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-
| Date | Jan 21, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Carestream Health Inc, sent an "URGENT: Medical Device Recall" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of |
| Quantity | 840 units Total (181 units domestically & 659 units internationally) |
| Distribution | Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091889 | DRX-EVOLUTION, MODEL VX3733-SYS Carestream Health, Inc., Jul 20, 2009 |