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KLARITY MEDICAL

Klarity Medical Products, LLC · Model R616-AE5 · UDI-DI 00817355028647

IYE

510(k) clearances

3,073

Adverse events (20 deaths)

563

Recalls

115

Facilities

Description

Klarity Uno™ Prone Belly Cushion Set. Includes Upper Prone Cushion with Removable Port Cushions, Tilting Prone Head Support, Upper Hand Grips, Lower Prone Cushion with Groin Lock and Removable Pelvic Hole Cushion, Leg Bolster, Upper Prone Cushion Indexing Bar, and Lower Prone Cushion

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.

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Data 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.