Recall Z-0132-2014 ยท IZL System, X-Ray, Mobile
Carestream Health Inc.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
| Date | Nov 1, 2013 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. |
| Root cause | Device Design |
| Action | The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to |
| Quantity | 331 units |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Si |
| 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 |