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
- Company
- Carestream Health, Inc.
- Recall Initiated
- January 12, 2017
- Terminated
- June 13, 2018
- Recall Number
- Z-1138-2017
- Quantity
- US: 1403 units; Foreign: 1370 units
- Firm Location
- Rochester, NY
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
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.
Lot / Code Info
Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)
Root Cause
Device Design
Action Taken
Carestream Health Inc. sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated December 29, 2016, and response forms were sent to the US customers via Certified Mail-Return Receipt Requested on January 12, and January 13, 2017, informing them of the problem. Customers are instructed to read and complete all information and return the response form within 5 working days to the following e-mail address: postmarketra@carestream.com, or fax the completed form to (585) 454-4493. UMDC Letters and Response Forms to Canadian Customers were sent the week of January 9, 2017, via courier. Field Safety Notice (FSN) Letters for the rest of world are in process. FSN Letters for the EMEA should be sent via courier starting later this week. US Carestream Customer Care Center #: 1-800-328-2910 (24/7). Outside of the US, please call your local Service support number.