Z-1138-2017 Class II Terminated
FDA device recall Z-1138-2017 was initiated by Carestream Health Inc on January 12, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 13, 2018). Affected quantity: US: 1403 units; Foreign: 1370 units.
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
Reason for Recall
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.