Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intende…
Due to pediatric defibrillator electrode delamination