Health product recall

LIFEPAK ® 35 Monitor/Defibrillator

Last updated

Summary

Product
LIFEPAK ® 35 Monitor/Defibrillator
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

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
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-82590

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