Day

August 10, 1999
Nucletron Plato External Beam Planning Radiation Therapy SoftwareV2.1.2 and MLC/Shape Software Module V2.3 Recall #Z-038-0. REASON Coordinates for radiation beam used in therapy are mislabeled in software. CODE Plato RTS software version V2.1.2 used with software module MLC/Shape version V2.3. MANUFACTURER Nucletron BV, The Netherlands. RECALLED BY Nucletron Corporation, Columbia, Maryland, by letter and customer...
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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