Philips Achieva 3.0T PET imaging device poses potential fire hazard
A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a fire hazard in medical equipment. Although the potential consequences (smoke/fire) are serious, no injuries, deaths, or confirmed incidents are reported in the source. Per the severity rubric, risk-of-harm products without reported injury receive a High (3) rating.
Plain-English summary
Philips North America LLC is recalling the Achieva 3.0T TX for PET imaging device (Model 781479, Serial Number 43102) due to a fire hazard.
The global Mains Distribution Unit (g-MDU) L3 terminal connection may become loose, creating an electrical hotspot. This defect could result in smoke or fire in hospital facilities.
The device has been distributed worldwide, including throughout the United States and 25 additional countries: Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
The recalled product
- Product
- Achieva 3.0T TX for PET Model Number (REF): 781479
- Manufacturer
- Philips North America Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: N/A Serial Numbers: 43102
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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