Philips Recalls Ingenia MRI Systems Due to Incorrect Nut Material
Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.
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 does not report any injuries, illnesses, or specific safety hazards resulting from the incorrect nut material, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling 24 Ingenia 1.5T magnetic resonance imaging systems. The recall affects specific units shipped between December 2013 and March 2014.
The recall was initiated because cover set rear magnetic M10 nuts were erroneously supplied instead of the required A4 stainless steel nuts. This defect involves the material composition of the hardware used in the system's cover set.
The affected systems were distributed worldwide, including in the United States and numerous international markets. The source text does not specify instructions for consumers or healthcare providers regarding immediate action, but the recall is managed by the recalling firm, Philips Medical Systems, Inc.
The recalled product
- Product
- Ingenia 1.5T, magnetic resonance imaging system.
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 24
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: 781396
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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