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DR-ID 1305SE
FUJIFILM CORPORATION · Model DR-ID 1305 SE E · UDI-DI 04547410322927
MQB
Prescription
1
510(k) clearances
1,277
Adverse events (11 deaths)
195
Recalls
127
Facilities
Description
The DR-ID 1305SE incorporates a GOS indirect panel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-01 | Philips North America Llc | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. |
| 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. additional force/ph |
| 2023-05-19 | Philips North America Llc | There is a software login in issue that may prevent the user from logging in. |
| 2021-09-22 | Philips Healthcare | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation W |
| 2021-03-11 | LIEBEL-FLARSHEIM COMPANY LLC | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual valu |
| 2021-02-05 | Canon Medical System, USA, INC. | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| 2020-12-08 | Canon Medical System, USA, INC. | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. |
| 2020-04-06 | Siemens Medical Solutions USA, Inc | It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will |
| 2020-03-03 | Canon Medical System, USA, INC. | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| 2020-01-07 | Palodex Group Oy | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.