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Edwards Lifesciences LLC · Model 70ANM7 · UDI-DI 00690103181579
DXG
Prescription
1
510(k) clearances
772
Adverse events (16 deaths)
8
Recalls
63
Facilities
Description
PRESSURE SLAVE CABLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-19 | Lidco Ltd | The expiration date on labeling is incorrect. |
| 2020-11-09 | ICU Medical, Inc. | Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. |
| 2020-02-14 | ICU Medical, Inc. | Firm identified software issues which leads to the patient ID and patient information not being stored in the system. |
| 2019-06-05 | GETINGE US SALES LLC | The monitor displays an error message . The error message states "internal error restart or service". |
| 2013-03-28 | Transonic Systems Inc | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. |
| 2010-06-25 | Edwards Lifesciences, Llc | The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated. |
| 2008-09-12 | Edwards Lifesciences, Llc | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00 |
| 2007-05-17 | Edwards Lifesciences, Llc | MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of syst |
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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.