Reported Jul 5, 2017 · Terminated
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors,…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Masimo SPO2 Sensor
- ear clip-adult (Merge Part NumberHW-HEMO-00047)
- Product UsageMerge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output
- Lot codes and dates
- The following lot numbers are affected and are
- not specific to each cable/sensor type
09AP810AEU10KBN09CF910BMN10MDN09CNS10FEN10MDN09KG610F9510DUT09KG610F9510DDK09NMN10BMN10DUT10A8110GJB10KBS09NMN10BMN10DUT10AEU10GJB10KBS10AEU10KBN10KBS11AGS11KAJ11CFT10KFP11N6111DAY11AGS11NG211CFT11AGS12CNX11DDK12FMH12C6811FBS12GEB12C6811JBK12GEBand 12FMH
- Amount recalled
- 2 sensors
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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