Recall Z-2651-2017 ยท IZL System, X-Ray, Mobile
Carestream Health Inc
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
| Date | Jun 19, 2017 (initiated May 25, 2017) |
| Status | Terminated |
| Reason | Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly. |
| Root cause | Process control |
| Action | Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910. |
| Quantity | Domestic: 1449 units; Foreign: 1416 units |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc., Apr 13, 2012 |