Nellcor MAXAL-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884522042444), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K012891); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• InjuryAug 22, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READINGS THAT DID NOT CORRELATE TO PATIENTS' BLOOD GASSES. IT WAS STATED THAT PATIENT WERE GETTING NORMAL SATURATION READINGS AND ABRUPTLY DROPPED TO 60S AND 70S WHICH LED TO OVER TREATING PATIENTS. THEY SWAPPED THE SENSORS, CABLES AND MULTI MEASUREMENT SERVERS WITH NO CHANGE. THE SPO2 WAS LOW COMPARED TO ABG'S USING OTHER DEVICE. CLINICAL INTERVENTION BASED ON SPO2 POSTED VALUES, PRIOR TO ABG VALUES BEING ASSESSED, PATIENT WAS PARALYZED WHICH WAS MEDICALLY INDUCED AND HYPER-OXYGENATED.

  Patient problems: Paralysis

  MAUDE report 8923865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

• Z-0664-05 · Oct 18, 2004 · Terminated
  Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.