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Irradiator, Blood To Prevent Graft Versus Host Disease

FDA product code MOT · Class U · Unknown

6
Registered devices
7
Adverse events
2
Recalls
16
510(k) clearances

Devices with this code

RADGIL2 — GILARDONI SPAGammacell — Best Theratronics LtdRaycell — Best Theratronics LtdRaycell — Best Theratronics LtdRS — RAD SOURCE TECHNOLOGIES, INC.Gammacell — Best Theratronics Ltd

Recent recalls

DateFirmReason
2016-05-06BEST THERATRONICS LTD.It was discovered that both the new device and the predicate device failed to comply with performance standard.
2002-06-01Rad-Source Technologies, Inc.The firm completed a cooling system retrofit to preclude overheating and failure.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.