Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37545 |
| Brand Name: | Physio-Control LIFEPAK 35 defibrillator/monitor |
| Model: | LIFEPAK 35 Monitor/Defib |
| Affected: | Catalogue number - 70335-000016, 70335-000017, 70335-000030, 70335-000018, 70335-000034 |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | Physio-Control Corporation |
| Issue: | 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 Inconclusive" prompt may not be displayed. Device functionality, rhythm analysis, and therapy delivery are unaffected. Problem 2: Certain printer and modem access port connectors may not have been fully seated during manufacturing, resulting in improper connector positioning within the rear housing assembly. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/9/2026 |
