Z-2651-2017 Class II Terminated
FDA device recall Z-2651-2017 was initiated by Carestream Health Inc on May 25, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 13, 2018). Affected quantity: Domestic: 1449 units; Foreign: 1416 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 25, 2017
- Termination Date
- June 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 1449 units; Foreign: 1416 units
Product Description
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
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 Pattern
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.
Code Information
Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482