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CCO/Sco2 interface module kit(FRU)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model 115-047022-00 · UDI-DI 06936415919092

DXG Prescription

510(k) clearances

772

Adverse events (16 deaths)

Recalls

Facilities

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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Data 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.