Recall Z-0289-2024 ยท IZL System, X-Ray, Mobile
Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly f
| Date | Nov 9, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable. |
| Root cause | Component design/selection |
| Action | An MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/27/23 was sent to customers. Actions To Be Taken by User Facility: " Inform all personnel that utilize the system of the potential issue. " Should an event of this nature occur: o Move the system away from patients/staff. o The system will be inoperable. o Call the Carestream Customer Care Center in the U.S. at 1-800-328-2910, your local Carestream Service support number or Carestream Health Authorized Representative to place a service call. " If an Adverse Health Event is encountered, notify FDA MedWatch o MedWatch: Use th |
| Quantity | 2402 systems |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191025 | DRX-Revolution Mobile X-ray System Carestream Health, Inc., May 17, 2019 |