Philips Ingenuity Core 128 MRI Software Recall for Timer Error
Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.
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 is classified as FDA Class II, and the source text does not explicitly state that no injuries or illnesses have been reported, nor does it confirm that the hazard is purely theoretical. Therefore, it is scored as High (3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 509 units of the Ingenuity Core 128 MRI system, model 728323. The recall is due to a software error associated with the filament on timer.
The affected units were distributed worldwide, including all 50 U.S. states and numerous international locations. The source text does not specify the exact nature of the hazard or any reported injuries or illnesses associated with this software error.
Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address this software issue.
The recalled product
- Product
- Ingenuity Core 128 728323
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 509
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 (20)
- 30016
- 30023
- 30024
- 30151
- 32000
- 32001
- 32008
- 32010
- 32012
- 32013
- 32015
- 32016
- 32018
- 32021
- 32022
- 32024
- 32026
- 32028
- 32032
- 32033
Distribution
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) 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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