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

    • 00884838066588
    • Serial No. 36987
    • 36587
    • 36690
    • 36898
    • 37009
    • 36637
    • 37129
    • 37140
    • 36957
    • 36549
    • 36548
    • 36547
    • 36893
    • 36678
    • 36736
    • 36743
    • 36744
    • 36763
    • 36770
    • 36882
    • 36897
    • 36938
    • 36939
    • 37012
    • 36585
    • 36622
    • 36618
    • 36639
    • 36635
    • 36650
    • 36648
    • 36732
    • 36681
    • 36676
    • 36769
    • 36861
    • 36885
    • 36878
    • 36883
    • 36890
    • 36894
    • 36950
    • 36941
    • 36994
    • 37000
    • 36998
    • 36993
    • 37130
    • 37159
    • 37160
    • 36874
    • 37032
    • 37053
    • 37208
    • 37127
    • 37148
    • 37151
    • 37143
    • 36559
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.