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Terminated

OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

FDA Recall Z-2267-2015 · Posted 2015-07-27

Recalling FirmCovidien LP (formerly Nellcor Puritan Bennett Inc.)
Recall StatusTerminated
Product CodeDQA
Date Initiated2015-06-29
Date Terminated2017-11-03
Product Quantity211,426 units

Reason for Recall

Potential missing segments on the display that can result in misinterpretation of data.

Firm Action

Metronic sent an Urgent Medical Device Correction letter dated June 29, 2015 to affected customers. The letter identified the adfected product, problem and actions to be taked. Customers where instructed to return the attached verification form. For questions contact your Medtronic representative.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide including Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIENCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013-05-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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