Reported Dec 4, 2024 · Ongoing

dS Breast 16ch 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 16ch 1.5T
Lot codes and dates
  • REF
    • 453530280721
    • 453530280723
    • 459801290511
    • 459801290514
    • 459801729882
  • UDI

    522 of 522 codes

    • 00884838066854
    • 00884838086425
    • 00884838118393
    • Serial No. 482
    • 508
    • 119
    • 40
    • 318
    • 394
    • 443
    • 41
    • 286
    • 120
    • 264
    • 412
    • 426
    • 457
    • 476
    • 342
    • 154
    • 319
    • 368
    • 409
    • 176
    • 35
    • 265
    • 416
    • 392
    • 437
    • 493
    • 529
    • 500
    • 526
    • 517
    • 531
    • 533
    • 276
    • 430
    • 509
    • 333
    • 356
    • 370
    • 445
    • 510
    • 53
    • 125
    • 117
    • 268
    • 174
    • 175
    • 282
    • 310
    • 452
    • 425
    • 399
    • 389
    • 442
    • 442
    • 303
    • 505
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, 7:40 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.