Z-1138-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 12, 2017
- Termination Date
- June 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 1403 units; Foreign: 1370 units
Product Description
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reason for Recall
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
Code Information
Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)