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MR-RT
Philips Medical Systems Nederland B.V. · Model RT CouchTop XD · UDI-DI 00884838112780
MUJ
Prescription
10
510(k) clearances
804
Adverse events (11 deaths)
267
Recalls
55
Facilities
Description
The Ingenia MR-RT aids the planning of radiation therapy (RT). With the Ingenia MR-RT, you can acquire high-quality MR images in the same patient position as in radiation therapy. MR-RT CouchTop is a dedicated RT patient table replacing the diagnostic tabletop for imaging patients in the RT treatment position. The MR-RT CouchTop is a light, thin flat tabletop to be placed on an MR system. Not suitable for transferring the patient. The RT CouchTop XD is an exchangeable tabletop for Ingenia MR scanners. It is suitable for transferring the patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-20 | RAYSEARCH LABORATORIES AB | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, |
| 2026-05-20 | RAYSEARCH LABORATORIES AB | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
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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.