Recall Z-0800-2015 ยท IZL System, X-Ray, Mobile
Carestream Health Inc
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.
| Date | Dec 16, 2014 (initiated Nov 25, 2014) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | The firm, Carestream, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/20/2014 to US Consignees/customers via Certified Mail on 11/25/2014. Foreign accounts will be notified as soon as possible. The letter described the product, problem and actions to taken. The customers were instructed if they observe a loosened boom to follow the procedure for turning the system off; stop using the device and contact Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the U.S., call your local Service support number. Carestream Hea |
| Quantity | 629 units (Domestic: 358 units; Foreign: 271 units) |
| Distribution | 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, SWE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc., Apr 13, 2012 |