Radlink CR Pro 2200
RADLINK, INC. · Model CR201-1 · UDI-DI 00866389000150
Description
The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist.
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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