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
- Company
- Carestream Health, Inc.
- Recall Initiated
- May 25, 2017
- Posted
- June 19, 2017
- Terminated
- June 13, 2018
- Recall Number
- Z-2651-2017
- Quantity
- Domestic: 1449 units; Foreign: 1416 units
- Firm Location
- Rochester, NY
Reason for Recall
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.
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.
Lot / Code Info
Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482
Root Cause
Process control
Action Taken
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.