Z-2642-2017Class II

MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number...

Name: Z-2642-2017 MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number...
Creator: Merge Healthcare, Inc.
Published: 2016-04-04
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-04 / Terminated

FDA source

Merge Healthcare, Inc. began a recall of MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics... on 2016-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2642-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-06-29
Terminated: 2019-10-15
Recalling firm: Merge Healthcare Incorporated
Product: 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 code: DQA Oximeter
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.
FDA root cause: Component change control
Action: Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the affected product problem and actions to be taken.
Quantity in commerce: 4 sensors
Distribution: Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2642-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2640-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2641-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2642-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2643-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

Product code DQA

K051212Class IIModification to Lncs Oximetry SensorsMasimo Corporation / cleared 2005-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)