Class II

Medical Device Recall: dS Breast 7ch 1.5T

Philips North America Llc · November 4, 2024

Reason for Recall

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

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

5,231 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0539-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Llc Medical Device Recall: dS Breast 7ch 1.5T | SafeCheck