Z-0800-2015 Class II Terminated
FDA device recall Z-0800-2015 was initiated by Carestream Health Inc on November 25, 2014 and is designated Class II. Reason for recall: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System i… The recall status is terminated (terminated June 6, 2016). Affected quantity: 629 units (Domestic: 358 units; Foreign: 271 units).
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- November 25, 2014
- Termination Date
- June 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 629 units (Domestic: 358 units; Foreign: 271 units)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.