Philips North America Llc 2024-12-04 Health serious FDA
Health · FDA · Recall #FDA-Z-0537-2025
dS Breast 16ch 1.5T Recall
Issued December 4, 2024 · Philips North America Llc
In December 2024, Philips North America Llc recalled the dS Breast 16ch 1.5T, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential safety issue where a patient may be harmed while preparing for or during a scan.
What you should do
- 1 Stop using dS Breast 16ch 1.5T right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips North America Llc
- Category
- Health
- Recall date
- December 4, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0537-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America Llc has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.