Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2642-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge 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.

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: July 5, 2017

Recall Number: Z-2642-2017

Event ID: 76974

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 sensors

Code Information:

The following lot numbers are affected and are not specific to each cable/sensor type: 09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Distribution Pattern:

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated