Reported Dec 4, 2024 · Ongoing

Mammotrak Interventional Coil 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?

  • Mammotrak Interventional Coil 1.5T
Lot codes and dates
  • REF453530228882
  • UDI-DI
    • 00884838066779
    • Serial No. 69
    • 82
    • 143
    • 64
    • 77
    • 87
    • 76
    • 81
    • 134
    • 124
    • 141
    • 103
    • 135
    • 138
    • 73
    • 72
    • 131
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, 7:01 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.