Home › Device types › KPR
System, X-Ray, Stationary
FDA product code KPR · Class 2 · Radiology
917
Registered devices
1,218
Adverse events
168
Recalls
356
510(k) clearances
Devices with this code
Q-RAD System — CARESTREAM HEALTH, INC.Radmedix — RADMEDIX, LLCDRGEM — DRGEM CorporationFDR Clinica — DRGEM CorporationQ-RAD System — CARESTREAM HEALTH, INC.Radmedix AcuityUDR — RADMEDIX, LLCDRX - Ascend System — CARESTREAM HEALTH, INC.VISION — VISARIS DOODRGEM — DRGEM CorporationRADspeed Pro — SHIMADZU CORPORATIONGXR-ES,ECS Diagnostic X-ray System — DRGEM CorporationDRX-Evolution Plus System — CARESTREAM HEALTH, INC.FDR Clinica — DRGEM CorporationDRGEM — DRGEM CorporationDRX-Evolution Plus System — CARESTREAM HEALTH, INC.SEDECAL — SEDECALOverhead Tube Crane — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.X3C 2200 Digital Radiographic System — Imaging Dynamics Company LtdFDR Clinica — DRGEM CorporationNA — Samsung Electronics Co., Ltd.Q-RAD System — CARESTREAM HEALTH, INC.Q-RAD System — CARESTREAM HEALTH, INC.Q-Rad System — CARESTREAM HEALTH, INC.DRGEM — DRGEM Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-09 | FUJIFILM Healthcare Americas Corporation | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. |
| 2025-09-15 | FUJIFILM Healthcare Americas Corporation | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effect |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or |
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