Medical device recalls Moderate risk

Philips North America Llc recalls dS Breast 7ch 3.0T

Recall date
November 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0540-2025
FDA classification
Class II
Brand / firm
Philips North America Llc
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

dS Breast 7ch 3.0T

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