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Computer, Diagnostic, Pre-Programmed, Single-Function

FDA product code DXG · Class 2 · Cardiovascular

387
Registered devices
772
Adverse events
8
Recalls
177
510(k) clearances

Devices with this code

EV1000 — Edwards Lifesciences LLCNA — Edwards Lifesciences LLCEDWARDS OXIMETRY CENTRAL VENOUS CATHETER — Edwards Lifesciences LLCLiDCO Ltd — LIDCO LIMITEDPRESEP — Edwards Lifesciences LLCAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHLiDCO Ltd — LIDCO LIMITEDTransonic — TRANSONIC SYSTEMS INC.LiDCO Ltd — LIDCO LIMITEDCARESCAPE B450 — GE Healthcare Finland OyShp Unit PiCCO Pod — DRAEGER MEDICAL SYSTEMS, INC.LiDCO Ltd — LIDCO LIMITEDLiDCO Ltd — LIDCO LIMITEDLiDCO Ltd — LIDCO LIMITEDScvO2 Module — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Transonic — TRANSONIC SYSTEMS INC.LiDCO Ltd — LIDCO LIMITEDRetia Medical — RETIA MEDICAL, LLCNA — GE Healthcare Finland OyLiDCO Ltd — LIDCO LIMITEDSureSigns VSi — Philips Medical Systems HsgICU Medical — ICU MEDICAL, INC.FLOTRAC, VAMP, TRUWAVE — Edwards Lifesciences LLCTransonic — TRANSONIC SYSTEMS INC.

Recent recalls

DateFirmReason
2020-11-19Lidco LtdThe expiration date on labeling is incorrect.
2020-11-09ICU Medical, Inc.Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
2020-02-14ICU Medical, Inc.Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
2019-06-05GETINGE US SALES LLCThe monitor displays an error message . The error message states "internal error restart or service".
2013-03-28Transonic Systems IncTransonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
2010-06-25Edwards Lifesciences, LlcThe recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
2008-09-12Edwards Lifesciences, LlcEdwards 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.
2007-05-17Edwards Lifesciences, LlcMAP 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.