FDA Recall Information

Stryker is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed. This is a result of oxidation that may have formed over time within the “Shock” button.

Stryker is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.

RECOMMENDATION: Stryker is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the operating instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK- COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 monitor/defibrillator Operator’s Checklist, number 7).

Link to recall: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stryker-launches-voluntary-field-action-specific-units-lifepakr-15-monitordefibrillator-0?utm_campaign=FDA%20MedWatch%20-%20LIFEPAK%2015%20Monitor%2FDefibrillators%20by%20Stryker%3A%20Recall&utm_medium=email&utm_source=Eloqua#recall-announcement