Philips ACS-NT MRI Scanner Recalled for Helium Gas Leak Risk
Philips is recalling 8,205 ACS-NT MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.
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: The recall involves a risk-of-harm product (asphyxiation hazard from helium gas) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 8,205 units of the ACS-NT, Model 78108 MRI scanner. The device is indicated for use as a diagnostic device to produce cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities.
The recall is issued due to a potential risk for helium gas inside the MR examination room during a magnet quench. The affected units were distributed worldwide, including across the United States and numerous international locations.
Healthcare facilities should contact Philips for instructions on how to address the potential hazard. Consumers should not use the device until the issue is resolved by the manufacturer.
The recalled product
- Product
- ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 8,205
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips Electronics North America Corporation 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.
See all 13 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · asphyxiation
See all →- Severe
- Severe
- Severe
- Severe
- Severe
Similar recalls
- HighMRI System Patient Support Table Floor Plate May Be Incorrectly Installed
FDA (Devices) · 2024-04-24
- SeverePhilips MR RT MRI Systems Recalled for Falling Ceiling Speaker Hazard
FDA (Devices) · 2019-03-06
- HighPhilips Achieva MRI Systems Recalled Due to Ceiling Speaker Hazard
FDA (Devices) · 2019-03-06
- SeverePhilips Achieva 3.0T MRI System Recalled for Ceiling Speaker Hazard
FDA (Devices) · 2019-03-06
- SeverePhilips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard
FDA (Devices) · 2016-07-06
- SeverePhilips Achieva 3.0T MRI System Recalled Due to Ceiling Speaker Hazard
FDA (Devices) · 2019-03-06