Philips North America Llc: Device Recall
Recall #Z-1862-2024 · 05/03/2024
Recall Details
- Recall Number
- Z-1862-2024
- 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
- Product Quantity
- 200 units
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
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
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