Recall MonitorHealth Products
LIFEPAK 15 V4 SpCO/SpMet Sensors
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: LIFEPAK 15 V4 SpCO/SpMet Sensors
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.