Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Nut Components
Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.
What this means for you
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 does not report any injuries, illnesses, or specific safety hazards beyond the incorrect component supply, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling 21 Ingenia 3.0T R5 magnetic resonance imaging systems. The recall affects specific units shipped between December 2013 and March 2014. The issue involves the cover set rear magnetic M10 nuts, which were erroneously supplied as standard nuts instead of the required A4 stainless steel nuts.
The affected systems were distributed worldwide, including nationwide in the United States and in numerous other countries. The specific model number for the affected units is 781342.
Consumers and healthcare facilities should contact Philips Medical Systems, Inc. for instructions on how to resolve the issue with the incorrect components.
The recalled product
- Product
- Ingenia 3.0T R5, magnetic resonance imaging system.
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 21
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)
- Model Numbers: 781342
Distribution
Part of a larger recall action
This product is one of 4 recalled by Philips Medical Systems, Inc. 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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