Rochester, NY, US · 13 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Class II | Radiology | 5 | 2026-01-20 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 4 | 2022-01-14 |
| IZL | System, X-Ray, Mobile | Class II | Radiology | 3 | 2026-03-11 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-09-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-10-02 | Class II | Ongoing | Z-0437-2024 | DRX Revolution Mobile X-Ray System | — | Unexpected failure of electrical components within the CPI generator. |
| 2023-10-02 | Class II | Ongoing | Z-0289-2024 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology… | — | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-r… |
| 2023-01-30 | Class II | Ongoing | Z-1206-2023 | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiogr… | — | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexp… |
| 2020-01-06 | Class II | Terminated | Z-0806-2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and cont… | — | Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-11 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | IZL | Class II | Radiology |
| 2026-01-20 | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | KPR | Class II | Radiology |
| 2025-09-04 | K251168 | Image Suite | LLZ | Class II | Radiology |
| 2024-12-10 | K241505 | DRX-Revolution Mobile X-ray System | IZL | Class II | Radiology |
| 2024-03-12 | K233381 | DRX-Evolution Plus System | KPR | Class II | Radiology |
| 2023-01-20 | K223842 | DRX - Compass | KPR | Class II | Radiology |
| 2022-03-23 | K213568 | DRX-Rise Mobile X-ray System | IZL | Class II | Radiology |
| 2022-01-14 | K213307 | Eclipse II with Smart Noise Cancellation | MQB | Class II | Radiology |
| 2021-04-02 | K202441 | Eclipse II with Smart Noise Cancellation | MQB | Class II | Radiology |
| 2020-12-02 | K203159 | Lux 35 Detector | MQB | Class II | Radiology |
| 2020-06-26 | K201373 | DRX-Compass | KPR | Class II | Radiology |
| 2020-02-18 | K192894 | Vita Flex CR System with LLI | MQB | Class II | Radiology |
| 2020-01-22 | K193574 | Q-Rad System | KPR | Class II | Radiology |