CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Philips Ingenia Elition S MR System recalled by Philips North America
Philips North America is recalling Philips Ingenia Elition S MR System, distributed nationwide in the US. The recall was initiated on 22 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0459-2023
- FDA event ID
- 91195
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2022
- FDA classified
- 8 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2022 | Recall initiated by company | |
| 8 Dec 2022 | Classified by FDA | +16 days |
| 14 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Product as listed by the FDA
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Where it was distributed
US Nationwide.
Questions about this recall
Is Philips Ingenia Elition S MR System recalled?
Yes. Philips North America recalled Philips Ingenia Elition S MR System on 22 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0459-2023.
Why was it recalled?
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Which lots are affected?
Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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