Recall Z-0540-2025— Philips North America Llc

Name: FDA recall Z-0540-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-04

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-11-04. It names one FDA 510(k) clearance: K032576. Product: dS Breast 7ch 3.0T. Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-11-04
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K032576 — BIOPSY BREAST COIL, MODEL BBCMri Devices Corp.·cleared 2003-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

dS Breast 7ch 3.0T

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.