Recall Z-1138-2017 ยท IZL System, X-Ray, Mobile
Carestream Health Inc
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
| Date | Jan 12, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 Safet |
| Quantity | US: 1403 units; Foreign: 1370 units |
| 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, |
| 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 |