The Recall Desk

Manufacturer

Philips Medical Systems North America Co. Phillips

2 recalls in our database name Philips Medical Systems North America Co. Phillips as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2013-01-16

Of the 2 recalls from Philips Medical Systems North America Co. Phillips we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-0642-2013·2013-01-16

    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. Us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2013·2013-01-16

    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, the
    Category
    Medical Device
    Distribution
    Distributed nationwide