CanadaLIFEPAK 15 V4 SpCO/SpMet sensors are affected when used with specific lots of Masimo Rainbow sensors: LNCS‑II Rainbow DCIP 8 SpCO (model 4068, lot 23JBP), LNCS‑II Rainbow DCI 8 SpCO (model 4067, lots 23HPT, 23HER, 23JTA, 23GJQ, 23JBN) and RD Rainbow SpCO (model 4036, lot 23JAU). The device can display the error "SpO2: Sensor does not support SpCO or SpMET," preventing use of SpCO and SpMet functions. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Physio-Control, Inc., 11811 Willows Road North East, Redmond, Washington, United States, 98052.
How to identify it
Affected products: LNCS-II Rainbow DCIP 8 SpCO; Lot or serial number: 23JBP; Model or catalogue number: 4068
Affected products: LNCS-II Rainbow DCI 8 SpCO; Lot or serial number: 23HPT; Model or catalogue number: 4067
Affected products: LNCS-II Rainbow DCI 8 SpCO; Lot or serial number: 23HER; Model or catalogue number: 4067
Affected products: LNCS-II Rainbow DCI 8 SpCO; Lot or serial number: 23JTA; Model or catalogue number: 4067
Affected products: LNCS-II Rainbow DCI 8 SpCO; Lot or serial number: 23GJQ; Model or catalogue number: 4067
Affected products: LNCS-II Rainbow DCI 8 SpCO; Lot or serial number: 23JBN; Model or catalogue number: 4067
Affected products: RD Rainbow SpCO; Lot or serial number: 23JAU; Model or catalogue number: 4036
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States