Reported Jun 18, 2025 · Ongoing
Achieva XR Product Numbers: (1) 781153, (2) 781253;
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?
- Achieva XR Product Numbers
(1) 781153(2) 781253
- Lot codes and dates
- Product Numbers
(1) 781153(2) 781253
- UDI-DI
(1) no UDI(2) no UDI
- Serial NumbersAll serial numbers
- Product Numbers
- Amount recalled
- 6 units (5 US, 1 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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