Philips dStream MR System Terminal Connection May Become Loose and Cause Fire
Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.
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: FDA Class II device with potential for fire and smoke hazard from loose terminal connections. Although no deaths, injuries, or hospitalizations have been reported, the risk of fire in a medical facility constitutes a risk-of-harm product.
Plain-English summary
Philips North America LLC is recalling the Upgrade dStream Magnetic Resonance (MR) system, Model Number 782127 (Serial Number 65007). This is a medical imaging device used for diagnostic purposes in hospital settings.
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose over time. This loose connection can create a hotspot, which may cause smoke or fire in the hospital's technical room.
This device was distributed worldwide, including throughout the United States and in numerous countries such as Canada, Japan, the United Kingdom, and others.
Hospitals and healthcare facilities using this system should contact Philips North America LLC. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
- Manufacturer
- Philips North America Llc
- Affected units
- 1
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 Number: 65007
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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