Philips MR Systems Recalled for Magnet Energization Device Electrical Shock Risk
Philips is recalling four Ingenia Ambition MR systems because the Magnet Energization Device may have residual voltage, posing an electrical shock risk to personnel.
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 (electrical shock) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Philips Medical Systems Nederlands is recalling four Ingenia Ambition S and Ingenia Ambition X MR systems equipped with a Magnet Energization Device (MED). The recall is due to a potential electrical shock hazard.
The Magnet Energization Device can have a residual voltage on its output terminal. This condition may cause electrical shocks to personnel who are servicing the MED, the Magnet Drive Device (MDD), or connected cabling.
The affected units were distributed in the United States to Florida and internationally to Switzerland and Germany. The specific serial numbers involved are 47004 (US), 47001, 47002, and 48000 (International). Personnel should contact Philips Medical Systems Nederlands for further instructions on how to address this issue.
The recalled product
- Product
- Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
- Manufacturer
- Philips Medical Systems Nederlands
- Hazard
- Affected units
- 4
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 (3)
- US Serial Number: 47004 OUS Serial Numbers: 47001
- 47002
- 48000
Distribution
Distributed in 1 state:
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