Recall Z-2268-2015— Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Name: FDA recall Z-2268-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-29

Class II · Terminated

Class II FDA medical device recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), initiated 2015-06-29, terminated 2017-11-03. It names one FDA 510(k) clearance: K123581. Product: OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.. Reason: Potential missing segments on the display that can result in misinterpretation of data..

Recalling firm: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Terminated: 2017-11-03
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K123581 — NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIENCovidien, Formerly Nellcor Puritan Bennett, Inc.·cleared 2013-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.