The Recall Desk

FDA (Devices) recall action 89129

Philips North America Llc recalled 3 products on 2021-12-15

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-12-15
Critical
0
Units
1,685

Why these products were recalled

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

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.

1–3 of 3

  • HighFDA (Devices)··2021-12-15

    Philips BV Pulsera X-ray Systems Missing Required Temperature Documentation

    Philips has recalled BV Pulsera mobile X-ray systems due to missing temperature specifications in the instructions for use. The X-ray tank and image intensifier lack maximum surface temperature documentation, creating a burn hazard.

    Product
    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-12-15

    Philips BV Endura diagnostic X-ray system missing temperature specifications

    Philips BV Endura diagnostic X-ray systems lack specifications for maximum surface temperatures in their instructions, creating potential for burn injuries.

    Product
    BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-12-15

    Diagnostic X-ray imaging system recalled for incomplete temperature specifications

    Philips Veradius Unity diagnostic X-ray systems lack required temperature specifications in instructions, creating burn risk. Affected systems should not be used until updated documentation is received.

    Product
    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
    Category
    Distribution
    0 states