Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357

Class I - Dangerous

🏥 Medical Devices Recalled: August 11, 2021 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Serial Number Unique Device Identifier (UDI#) Model: 781357 46029 (01)00884838088108(21)46029 46053 (01)00884838088108(21)46053 46045 (01)00884838088108(21)46045 46027 (01)00884838088108(21)46027 46042 (01)00884838088108(21)46042 46084 (01)00884838088108(21)46084 46086 (01)00884838088108(21)46086 46083 (01)00884838088108(21)46083 46030 (01)00884838088108(21)46030 46031 (01)00884838088108(21)46031 46050 (01)00884838088108(21)46050 46049 (01)00884838088108(21)46049 46052 (01)00884838088108(21)46052 46076 (01)00884838088108(21)46076 46085 (01)00884838088108(21)46085 46024 (01)00884838088108(21)46024 46044 N/A 46061 N/A 46001 (01)00884838088108(21)46001 46005 (01)00884838088108(21)46005 46011 (01)00884838088108(21)46011 46012 (01)00884838088108(21)46012 46057 (01)00884838088108(21)46057 46048 (01)00884838088108(21)46048 46021 (01)00884838088108(21)46021 46066 (01)00884838088108(21)46066 46078 (01)00884838088108(21)46078 46081 (01)00884838088108(21)46081 46060 (01)00884838088108(21)46060 46004 (01)00884838088108(21)46004 46018 (01)00884838088108(21)46018 46020 (01)00884838088108(21)46020 46013 (01)00884838088108(21)46013 46015 (01)00884838088108(21)46015 46017 (01)00884838088108(21)46017 46016 (01)00884838088108(21)46016 46023 (01)00884838088108(21)46023 46033 (01)00884838088108(21)46033 46034 (01)00884838088108(21)46034 46037 (01)00884838088108(21)46037 46025 (01)00884838088108(21)46025 46041 (01)00884838088108(21)46041 46026 (01)00884838088108(21)46026 46032 (01)00884838088108(21)46032 46036 (01)00884838088108(21)46036 46059 (01)00884838088108(21)46059 46039 (01)00884838088108(21)46039 46075 (01)00884838088108(21)46075 46046 (01)00884838088108(21)46046 46068 (01)00884838088108(21)46068 46058 (01)00884838088108(21)46058 46054 (01)00884838088108(21)46054 46082 (01)00884838088108(21)46082 46069 (01)00884838088108(21)46069 46003 (01)00884838088108(21)46003 46019 (01)00884838088108(21)46019 46008 (01)00884838088108(21)46008 46007 (01)00884838088108(21)46007 46067 (01)00884838088108(21)46067 46089 N/A 46002 (01)00884838088108(21)46002 46014 (01)00884838088108(21)46014 46065 (01)00884838088108(21)46065 46077 (01)00884838088108(21)46077
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Philips North America Llc
Reason for Recall:: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: completed

Product Information

Full Description:

Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357

Product Codes/Lot Numbers:

Serial Number Unique Device Identifier (UDI#) Model: 781357 46029 (01)00884838088108(21)46029 46053 (01)00884838088108(21)46053 46045 (01)00884838088108(21)46045 46027 (01)00884838088108(21)46027 46042 (01)00884838088108(21)46042 46084 (01)00884838088108(21)46084 46086 (01)00884838088108(21)46086 46083 (01)00884838088108(21)46083 46030 (01)00884838088108(21)46030 46031 (01)00884838088108(21)46031 46050 (01)00884838088108(21)46050 46049 (01)00884838088108(21)46049 46052 (01)00884838088108(21)46052 46076 (01)00884838088108(21)46076 46085 (01)00884838088108(21)46085 46024 (01)00884838088108(21)46024 46044 N/A 46061 N/A 46001 (01)00884838088108(21)46001 46005 (01)00884838088108(21)46005 46011 (01)00884838088108(21)46011 46012 (01)00884838088108(21)46012 46057 (01)00884838088108(21)46057 46048 (01)00884838088108(21)46048 46021 (01)00884838088108(21)46021 46066 (01)00884838088108(21)46066 46078 (01)00884838088108(21)46078 46081 (01)00884838088108(21)46081 46060 (01)00884838088108(21)46060 46004 (01)00884838088108(21)46004 46018 (01)00884838088108(21)46018 46020 (01)00884838088108(21)46020 46013 (01)00884838088108(21)46013 46015 (01)00884838088108(21)46015 46017 (01)00884838088108(21)46017 46016 (01)00884838088108(21)46016 46023 (01)00884838088108(21)46023 46033 (01)00884838088108(21)46033 46034 (01)00884838088108(21)46034 46037 (01)00884838088108(21)46037 46025 (01)00884838088108(21)46025 46041 (01)00884838088108(21)46041 46026 (01)00884838088108(21)46026 46032 (01)00884838088108(21)46032 46036 (01)00884838088108(21)46036 46059 (01)00884838088108(21)46059 46039 (01)00884838088108(21)46039 46075 (01)00884838088108(21)46075 46046 (01)00884838088108(21)46046 46068 (01)00884838088108(21)46068 46058 (01)00884838088108(21)46058 46054 (01)00884838088108(21)46054 46082 (01)00884838088108(21)46082 46069 (01)00884838088108(21)46069 46003 (01)00884838088108(21)46003 46019 (01)00884838088108(21)46019 46008 (01)00884838088108(21)46008 46007 (01)00884838088108(21)46007 46067 (01)00884838088108(21)46067 46089 N/A 46002 (01)00884838088108(21)46002 46014 (01)00884838088108(21)46014 46065 (01)00884838088108(21)46065 46077 (01)00884838088108(21)46077

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2418-2021

Related Recalls

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Philips North America

Class I - Dangerous

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Oct 27, 2025 Other Medical Devices View Details →

IntelliVue MP90. Product Number: M8010A.

Philips North America

Class I - Dangerous

Potential issue where the IntelliVue monitors did not alarm.

Oct 31, 2025 Infusion Pumps Nationwide View Details →

IntelliVue MP30. Product Number: M8002A.

Philips North America

Class I - Dangerous

Potential issue where the IntelliVue monitors did not alarm.

Oct 31, 2025 Infusion Pumps Nationwide View Details →