Philips North America Llc: Device Recall
Recall #Z-1846-2024 · 05/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1846-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America Llc
- Status
- Ongoing
- Date Initiated
- 05/03/2024
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Product Description
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Other Recalls by Philips North America Llc
- Class II: Risk 12/12/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.