Physio-control Lifepak 35 Defibrillator/monitor
Recall Summary Physio-Control LIFEPAK 35 defibrillator/monitor devices are being recalled due to two manufacturing issues. First, under certain manual mode settings, the device may fail to display a "CHECK RHYTHM / ECG Analysis Inconclusive" message, though the device still correctly analyzes rhythms and delivers therapy as needed. Second, some printer and modem connectors may not be properly seated in the rear housing. These devices were distributed to hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- Stryker New Zealand Ltd
- Product
- Physio-Control LIFEPAK 35 defibrillator/monitor. [Device]. Model: LIFEPAK 35 Monitor/Defib. Affected: Catalogue number - 70335-000016, 70335-000017, 70335-000030, 70335-000018, 70335-000034
- Reason
- The manufacturer has identified a problem with the LP35 where the device does not display the message "CHECK RHYTHM / ECG Analysis Inconclusive" as intended when all below conditions are present simultaneously. The problem 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 and rhythm analysis is not impacted by this problem., Problem 1: Under a specific combination of non-default Manual Mode settings, the "CHECK RHYTHM / ECG Analysis...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-14
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8b7df074-4aa9-4657-9729-76275e28091f