Philips MRI Systems Recalled for Potential Water Freezing in Venting System
Philips Medical Systems is recalling 511 MRI systems because water may collect and freeze in the vent pipe, potentially blocking the magnet venting system.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no injuries or illnesses have been reported. The hazard is a mechanical blockage of the venting system, which is a theoretical risk of harm rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling specific models of Magnetic Resonance Imaging (MRI) systems, including the Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, and Panorama 0.6T/1.0T. These systems are intended for clinical and radiologic diagnostic imaging applications.
The recall is due to a potential defect where water may collect in the vent pipe elbow of the magnet venting system. If the water freezes, it could block the venting system. The recall covers a total of 511 units distributed nationwide in the United States, including Florida, Colorado, Kentucky, Mississippi, Pennsylvania, North Carolina, New Jersey, Texas, and Puerto Rico, as well as internationally to Italy.
Healthcare facilities and users of these MRI systems should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
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 (15)
- M/N: 781220
- 781230
- 781301
- 78129 and 78127. Codes: AM128
- 1510
- 1518
- BA318
- AM120
- ZA178
- ZA196
- ZA107
- ZA133
- ZA172
- ZA158
- BA149 and ZA208.
Distribution
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