CanadaLIFEPAK 35 Monitor/Defibrillator units with model/catalogue numbers 70335-000180, 99335-000123, 99335-000124, 70335-000182, 70335-000185, 99335-000126, 70335-000184, 99335-000121, 70335-000183, 99335-000035, 99335-000125, 70335-000047, 70335-000181 and 99335-000122 are affected. The devices may not display the on-screen message "CHECK RHYTHM / ECG Analysis Inconclusive" under specific simultaneous conditions; this does not affect the display of "shock advised" or "no shock advised," therapy delivery, or rhythm analysis. Contact the manufacturer for 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: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000180
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000123
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000124
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000182
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000185
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000126
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000184
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000121
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000183
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000035
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000125
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000047
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 70335-000181
Affected products: LIFEPAK ® 35 Monitor/Defibrillator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 99335-000122
The hazard
Stryker has identified an issue with the LP35 where the device does not display the message "CHECK RHYTHM / ECG Analysis Inconclusive" as intended when specific conditions are present simultaneously. The issue does not affect the display of "shock advised" or "no shock advised" messages, and therapy delivery remains available. Additionally, this nonconformance is limited to the device on-screen prompts only; rhythm analysis is not impacted by this issue.
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