fda
13 records
FDA Device Recall: Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-4
2018-05-16
Class II — The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
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FDA Recall: Transonic Systems Inc — Class II
20150909
Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow pr | Product: Transonic Flow Probe, 3 mm, Catalog Nu...
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FDA Recall: Transonic Systems Inc — Class II
20150325
Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero | Product: Transonic Hemodialysis Monitor, Model ...
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FDA Device Recall: Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measu
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measur
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measu
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to mea
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measu
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to meas
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to mea
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measur
2015-09-09
Class II — Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the me...
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FDA Device Recall: Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodial
2015-03-25
Class II — Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on H...
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FDA Device Recall: HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Lo
2013-04-24
Class II — Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
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ny_corps
1 records
NY Corp: TRANSONIC SYSTEMS INC.
1983-07-01
DOMESTIC BUSINESS CORPORATION | County: Tompkins | Jurisdiction: New York
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