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Standard Imaging IVB 1000 Well Chamber

STANDARD IMAGING INC. · Model 90009 · UDI-DI 00866562000250

KPTIWJJAQ Prescription
10
510(k) clearances
1
Adverse events
4
Recalls
2
Facilities

Description

Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements.

Recalls

DateFirmReason
2021-08-16Biodex Medical Systems, Inc.When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorr
2021-08-16Biodex Medical Systems, Inc.When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorr
2011-07-08Capintec IncSoftware error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
2010-09-20Capintec IncThe spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and

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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.