Agency classClass IIOur severity:High FDA (Devices)·Z-2642-2017·Announced 2017-07-05

Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (delay in patient care) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Merge Healthcare, Inc. is recalling four MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensors (finger clip pediatric, Part Number HW-HEMO-00076). These sensors are used with Merge Hemodynamics monitors to measure physiologic data, including SpO2, during cardiac catheterization procedures.

The recall was initiated because, under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient's SpO2. This failure could cause a slight delay in patient care. The affected lot numbers are listed in the agency's structured data and are not specific to each cable or sensor type.

Distribution was nationwide, including government and military channels, with no foreign distribution. Users should contact Merge Healthcare for instructions on how to proceed with the recall.

The recalled product

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.…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Monitoring Equipment
Hazard: display-failure
delayed-care
Affected units: 4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

10AEU
10KBN
09CF9
10BMN
10MDN
09CNS
10FEN
09KG6
10F95
10DUT
10DDK
09NMN
10A81
10GJB
10KBS
11AGS
11KAJ
11CFT
10KFP
11N61

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Merge Healthcare, Inc.

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Same hazard · display failure