Nellcor MAXPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522042311), received between Jan 31, 2024 and Jan 31, 2024 — classified as 1 malfunction.

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.

• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD NO VALUES. THE SENSOR WAS REPLACED AND HAD NO VALUES AGAIN. IT WAS POWERED OFF AS NO VALUES AND INTERFERENCE WITH STANDARD OF CARE PULSE OXIMETER VALUES. IT WAS REPLACED AGAIN WITH ANOTHER SENSOR AND PLACED ON LEFT EAR LOBE, THE VALUES SHOWED LOW SPO2 NOT CORRELATING WITH STANDARD OF CARE PULSE OXIMETER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613726 ↗

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.