The Recall Desk

FDA (Devices) recall action 85560

Philips North America, LLC recalled 2 products on 2020-06-10

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
2020-06-10
Critical
0
Units
3,435

Why these products were recalled

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

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)··2020-06-10

    Philips Chest Pneumograph Recalled for Missing Latex Labeling

    Philips is recalling Chest Pneumograph accessories because the labeling does not state that the product contains natural rubber latex.

    Product
    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-06-10

    Philips Chest Pneumograph Recalled for Missing Natural Rubber Latex Labeling

    Philips is recalling 1,075 Chest Pneumograph units because the labeling fails to state that the product contains natural rubber latex.

    Product
    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest…
    Category
    Distribution
    0 states