Recall Z-1877-2013 ยท KPR System, X-Ray, Stationary
Carestream Health Inc.
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
| Date | Aug 12, 2013 (initiated Jun 3, 2013) |
| Status | Terminated |
| Reason | Due to potential for an x-ray exposure technique change. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. C |
| Quantity | US: 49 units; Foreign: 183 units (revised) |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom. |
| 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 |