Reported Jun 18, 2025 · Ongoing
Intera 1.5T Achieva Nova Product Number: 781172;
Philips North America
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 · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- Intera 1.5T
- Achieva Nova Product Number781172
- Lot codes and dates
- Product Number781172
- UDI-DIno UDI
- Serial Numbers
21218212172121621289213491214612063120862006921027211981209918641214761862312078
- Amount recalled
- 16 units (1 US, 15 OUS)
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
This product could cause temporary or reversible health problems — stop using it.
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