The Recall Desk

FDA (Devices) recall action 94786

Philips North America Llc recalled 3 products on 2024-07-03

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
2024-07-03
Critical
0
Units
1,050

Why these products were recalled

Potential for coils to heat up and harm patients (burn).

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

  • SevereFDA (Devices)··2024-07-03

    Philips SENSE XL Torso Coil 1.5T Recalled for Overheating Risk

    Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.

    Product
    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-07-03

    Philips MR Torso Coil Recall: Potential Patient Burn Risk

    Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.

    Product
    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 98960
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-07-03

    Philips SENSE XL TORSO COIL Recall Due to Potential Patient Burn Hazard

    Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.

    Product
    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
    Category
    Distribution
    0 states