PlainRecalls
FDA Devices Moderate Class II Ongoing

dS Breast 16ch 1.5T

Reported: December 4, 2024 Initiated: November 4, 2024 #Z-0537-2025

Product Description

dS Breast 16ch 1.5T

Reason for Recall

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

Details

Recalling Firm
Philips North America Llc
Units Affected
5,231 units
Distribution
US Nationwide distribution.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
dS Breast 16ch 1.5T. Recalled by Philips North America Llc. Units affected: 5,231 units.
Why was this product recalled?
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0537-2025.