Z-0461-2023 Class II Ongoing
FDA device recall Z-0461-2023 was initiated by Philips North America Llc on Nov 22, 2022 and is designated Class II. Reason for recall: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. The recall status is ongoing. Affected quantity: 566 total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 566 total
Product Description
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Reason for Recall
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Distribution Pattern
US Nationwide.
Code Information
Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0461-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026