Recall MonitorHealth Products
LIFEPAK ® 35 Monitor/Defibrillator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: LIFEPAK ® 35 Monitor/Defibrillator
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 |
|---|---|---|
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000180 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000123 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000124 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000182 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000185 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000126 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000184 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000121 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000183 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000035 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000125 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000047 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 70335-000181 |
| LIFEPAK ® 35 Monitor/Defibrillator | More than 10 numbers, contact manufacturer. | 99335-000122 |
Issue
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.