Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors
Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient 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, and the hazard involves a risk of harm (delay in patient care) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling 219 SpO2 connecting cables (Part Number: HW-HEMO-00014) used with the Masimo LNCS sensor. These cables are used with Merge Hemodynamics monitors, which measure and record physiologic data from patients undergoing cardiac catheterization procedures.
The recall is being issued because, under certain conditions, the cables could stop displaying the patient's SpO2 (oxygen saturation) levels. This failure could cause a slight delay in patient care. The affected cables were distributed nationwide, including to government and military facilities, but were not distributed outside the United States.
Healthcare facilities should stop using the affected cables and contact Merge Healthcare for instructions on how to return or replace them. The recall covers specific lot numbers listed in the official FDA notice.
The recalled product
- Product
- SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), 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…
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 219
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.
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