Recall Z-0437-2024 ยท IZL System, X-Ray, Mobile
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System
| Date | Dec 1, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| Reason | Unexpected failure of electrical components within the CPI generator. |
| Root cause | Component design/selection |
| Action | Consignees were sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" on 10/02/2023. This notice requested that consignees inform all personnel that utilize the affected devices of the recall notice and to return the provided Consignee Notification Acknowledgement form completed. If a failure similar to the one associated with this recall event were to occur, users should move the system away from patients and staff, the system should be identified as inoperable, and a call should be made to Carestream Customer Care at 1-800-328-2910, your local service support number, or your Carestream Health Auth |
| Quantity | 3,961 units |
| Distribution | Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ire |
| 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 |