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Gammacell
Best Theratronics Ltd · Model 3000 · UDI-DI 07540146000029
MOT
Prescription
1
510(k) clearances
7
Adverse events
2
Recalls
4
Facilities
Description
Blood Irradiator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-05-06 | BEST THERATRONICS LTD. | It was discovered that both the new device and the predicate device failed to comply with performance standard. |
| 2002-06-01 | Rad-Source Technologies, Inc. | The firm completed a cooling system retrofit to preclude overheating and failure. |
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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.