Reported Dec 4, 2024 · Ongoing

dS Breast 7ch 1.5T

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 1.5T
Lot codes and dates
  • REF
    • 453530280881
    • 453530280882
    • 459801290431
    • 459801290432
  • UDI

    1,164 of 1,164 codes

    • 00884838066847
    • 00884838086111
    • Serial No. 507
    • 648
    • 409
    • 133
    • 596
    • 421
    • 613
    • 68
    • 121
    • 132
    • 757
    • 787
    • 622
    • 538
    • 687
    • 139
    • 357
    • 806
    • 838
    • 555
    • 615
    • 754
    • 813
    • 525
    • 70
    • 1755
    • 518
    • 594
    • 628
    • 662
    • 502
    • 653
    • 575
    • 629
    • 473
    • 281
    • 335
    • 367
    • 364
    • 567
    • 1672
    • 1683
    • 740
    • 144
    • 1673
    • 561
    • 1655
    • 445
    • 435
    • 1725
    • 1661
    • 823
    • 1720
    • 1736
    • 1711
    • 1788
    • 1774
    • 427
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, 5:42 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.