The Recall Desk

FDA (Devices) recall action 63030

Philips Medical Systems North America Co. Phillips recalled 2 products on 2013-01-16

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
2013-01-16
Critical
0
Units
814,598

Why these products were recalled

Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o

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.

1–2 of 2

  • ModerateFDA (Devices)··2013-01-16

    Philips HeartStart HS1 Defibrillators Recalled for Manual Clarification

    Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information in the Owner's Manual.

    Product
    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-01-16

    Philips HeartStart FRx AED Recall for Maintenance Manual Clarification

    Philips is recalling HeartStart FRx AEDs to clarify maintenance instructions in the Owner's Manual.

    Product
    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest.…
    Category
    Distribution
    0 states