The Recall Desk
ModerateFDA (Devices)·Z-2641-2017·Announced 2017-07-05

Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard causes only a 'slight delay in patient care' with no reported injuries or deaths, fitting the criteria for a moderate risk of harm.

Plain-English summary

Merge Healthcare, Inc. is recalling 2 Masimo SPO2 Sensor, ear clip-adult units (Merge Part Number: HW-HEMO-00047). These sensors are used with Merge Hemodynamics monitors to measure physiologic data, including SpO2, from patients undergoing 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 malfunction could cause a slight delay in patient care.

Distribution was nationwide, including government and military distribution, with no foreign distribution. The affected lot numbers are: 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. Healthcare facilities should contact Merge Healthcare for instructions on how to return the affected sensors.

The recalled product

Product
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), 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
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Monitoring Systems
Hazard
Affected units
2

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 →

Related recalls

Same manufacturer · Merge Healthcare, Inc.

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Same hazard · display failure

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