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
453530280891453530280892459801290711459801290712459801729911459801729911459801729912459801729913
- UDI-DI
1,338 of 1,338 codes
0088483806616800884838086173008848380984040088483810795300884838118294Serial No. 105063270998194410601757037231009102209227365514342509742753801819101346290391283386884388489210021038182170946980747219626907827840861854890871860850878891859894883889926
- REF
- 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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