Nellcor MAX-ALRecalls & reported problems

Hygia Health Services, Inc. · Nellcor OxiMax Adult Long Pulse Oximeter Sensor · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10817357020349), received between Nov 11, 2024 and Nov 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Low Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 11, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD LOW SPO2 READINGS. SENSOR WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652531 ↗

Device details

UDI-DI	`10817357020349`
Brand	Nellcor
Model	MAX-AL
Company	Hygia Health Services, Inc.
Product code	NLF · Oximeter, Reprocessed
Class	Class 2
FDA submission	K041867
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	Nov 10, 2021

Device type (GMDN): Pulse oximeter probe, reprocessed

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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All Oximeter, Reprocessed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.