FDAFDA · Food and drugs·Recall number Z-0800-2015
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
Published December 24, 2014 · Recall initiated: November 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health Inc
- Distributor
- 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.
- Lot
- Serial Numbers 101 to 764
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.