Reported Dec 4, 2024 · Ongoing

dS Breast 7ch 3.0T

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?

  • dS Breast 7ch 3.0T
Lot codes and dates
  • REF
    • 453530280891
    • 453530280892
    • 459801290711
    • 459801290712
    • 459801729911
    • 459801729911
    • 459801729912
    • 459801729913
  • UDI-DI

    1,338 of 1,338 codes

    • 00884838066168
    • 00884838086173
    • 00884838098404
    • 00884838107953
    • 00884838118294
    • Serial No. 1050
    • 632
    • 709
    • 981
    • 944
    • 1060
    • 175
    • 703
    • 723
    • 1009
    • 102
    • 209
    • 227
    • 365
    • 514
    • 342
    • 509
    • 742
    • 753
    • 801
    • 819
    • 1013
    • 462
    • 903
    • 912
    • 833
    • 868
    • 843
    • 884
    • 892
    • 1002
    • 1038
    • 182
    • 170
    • 946
    • 980
    • 747
    • 219
    • 626
    • 907
    • 827
    • 840
    • 861
    • 854
    • 890
    • 871
    • 860
    • 850
    • 878
    • 891
    • 859
    • 894
    • 883
    • 889
    • 926
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, 5:37 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.