Philips Recalls Ingenia 1.5T MRI Systems Due to Incorrect Hardware
Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.
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, which typically indicates a temporary or medically reversible adverse health consequence. The defect involves incorrect hardware (nuts) rather than a direct functional failure or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling 33 Ingenia 1.5T R5 magnetic resonance imaging (MRI) systems. The recall affects systems shipped between December 2013 and March 2014. The issue involves the cover set rear magnetic M10 nuts, which were erroneously supplied instead of the required A4 stainless steel nuts.
The affected units were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas, and Washington. The systems were also distributed in Mexico, Argentina, Australia, and numerous other countries worldwide.
Healthcare facilities should contact Philips Medical Systems for instructions on how to replace the incorrect hardware with the proper A4 stainless steel nuts. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Ingenia 1.5T R5, magnetic resonance imaging system.
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 33
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 Number: 781341
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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