Z-0546-2025Class II

SENSE Breast Coil 3.0T 7ch

Name: Z-0546-2025 SENSE Breast Coil 3.0T 7ch
Creator: Philips North America Llc
Published: 2024-11-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-11-04 / Open, Classified

FDA source

Philips North America Llc began a recall of SENSE Breast Coil 3.0T 7ch on 2024-11-04. FDA classified it as Class II and gives the reason as "Potential safety issue where a patient may be harmed while preparing for or during a scan". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0546-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-04
Posted: 2024-11-25
Recalling firm: Philips North America LLC
Product: SENSE Breast Coil 3.0T 7ch
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: Potential safety issue where a patient may be harmed while preparing for or during a scan.
FDA root cause: Use error
Action: An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at [email protected]. Customers with any questions are to contact their local Philips Representative.
Quantity in commerce: 5,231 units
Distribution: US Nationwide distribution.
Product codes and lots: REF: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0536-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0537-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0538-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0539-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0540-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0541-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0542-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0543-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0544-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0545-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0546-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0547-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0548-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25

Product code MOS

K041481Class IIModel Bbc-127 Biopsy Breast CoilMri Devices Corp. / cleared 2004-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)