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Summit Doppler
Coopersurgical, Inc. · Model SD5V · UDI-DI 00888937001990
JAF
Prescription
1
510(k) clearances
80
Adverse events (4 deaths)
8
Recalls
11
Facilities
Description
Vista 5.0 MHz Vascular Bidirectional Probe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-10 | Unetixs Vascular, Inc. | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| 2023-02-10 | Unetixs Vascular, Inc. | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| 2023-02-10 | Unetixs Vascular, Inc. | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| 2023-02-10 | Unetixs Vascular, Inc. | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| 2017-06-09 | Natus Neurology Inc | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood |
| 2017-06-09 | Natus Neurology Inc | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood |
| 2017-06-09 | Natus Neurology Inc | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood |
| 2017-06-09 | Natus Neurology Inc | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood |
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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.