FDANovember 4, 2024device

dS Breast 16ch 3.0T

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential safety issue where a patient may be harmed while preparing for or during a scan.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

45353028073145980129074145980129074445980172989145980172989200884838065840008848380861970088483809838100884838118041

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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dS Breast 16ch 3.0T — Recall Details · AllClear