Reported Dec 4, 2024 · Ongoing
SENSE Breast Coil
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- SENSE Breast Coil
- Lot codes and dates
- REF453530083951
- UDI-DI
371 of 371 codes
00884838066588Serial No. 3698736587366903689837009366373712937140369573654936548365473689336678367363674336744367633677036882368973693836939370123658536622366183663936635366503664836732366813667636769368613688536878368833689036894369503694136994370003699836993371303715937160368743703237053372083712737148371513714336559
- Amount recalled
- 5,231 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential safety issue where a patient may be harmed while preparing for or during a scan.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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