LIFEPAK 15 V4 SpCO/SpMet Sensors
Brand(s)
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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