Health product recall

LIFEPAK 15 V4 SpCO/SpMet Sensors

Last updated

Summary

Product
LIFEPAK 15 V4 SpCO/SpMet Sensors
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
LNCS-II Rainbow DCIP 8 SpCO 23JBP 4068
LNCS-II Rainbow DCI 8 SpCO 23HPT 4067
LNCS-II Rainbow DCI 8 SpCO 23HER 4067
LNCS-II Rainbow DCI 8 SpCO 23JTA 4067
LNCS-II Rainbow DCI 8 SpCO 23GJQ 4067
LNCS-II Rainbow DCI 8 SpCO 23JBN 4067
RD Rainbow SpCO 23JAU 4036

Issue

Stryker received complaints indicating that the LIFEPAK 15 V4 displayed an error where “SpO2: Sensor does not support SpCO or SpMET.” The error results in preventing users from utilizing LIFEPAK 15 V4 SpCO and SpMet functionalities when connected to specific lots of Masimo Rainbow Sensors.
The specific sensor lots are compatible with the LIFEPAK 15 V1 and V2 devices.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Physio-Control, Inc.

11811 Willows Road North East, Redmond, Washington, United States, 98052

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82104

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