Calypso System
VARIAN MEDICAL SYSTEMS, INC. · Model 3 · UDI-DI 00850011006115
Description
The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system’s detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are placed on the patient’s skin surface or implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective, continuous measurement of the localization of the treatment target in 3 dimensions. The system operator uses this information for patient alignment and continuous target positioning (i.e., tracking) during radiation therapy treatment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | PTW FREIBURG | When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorr |
| 2026-06-16 | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i |
| 2026-06-16 | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i |
| 2026-05-21 | Elekta, Inc. | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| 2025-12-14 | Elekta, Inc. | Due to a manufacturing issue and electrical grounding of systems. |
| 2025-12-10 | Elekta, Inc. | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or l |
| 2025-10-09 | C-RAD POSITIONING AB | Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the |
| 2025-09-17 | ELEKTA SOLUTIONS AB | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. |
| 2025-07-25 | Zap Surgical Systems | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat |
| 2025-04-22 | C-RAD POSITIONING AB | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs