Class II

Medical Device Recall: dS Breast 7ch 3.0T

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-0540-2025

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.