Home › Coopersurgical, Inc. › Summit Doppler
Summit Doppler
Coopersurgical, Inc. · Model L500VA · UDI-DI 00888937002485
JAF
Prescription
10
510(k) clearances
80
Adverse events (4 deaths)
8
Recalls
10
Facilities
Description
Vista AVS - Advanced ABI/Vascular System: On Screen Guide, PVR, 8.0 MHz Doppler probe, PPG, Auto Cuff Inflation/Deflation, Individual Site Mode, PC Software, Stand and 9 Cuffs
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.