The Recall Desk

FDA (Devices) recall action 84850

Philips North America LLC recalled 2 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-02-26
Critical
0
Units
44

Why these products were recalled

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2020-02-26

    Philips HeartStart AEDs Recalled for Quality Standards Defect

    Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.

    Product
    Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2020-02-26

    Philips HeartStart FRx AED Recalled for Quality Standards Violation

    Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.

    Product
    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
    Category
    Distribution
    9 states