Z-1842-2024 Class II Ongoing
FDA device recall Z-1842-2024 was initiated by Philips North America Llc on May 3, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- May 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
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
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.
Code Information
UDI-DI: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083 35022 35063 35074 35049 35035 35067 35004 35006 35011 35015 35016 35021 35050 35057 35061 35075 35076 35082 35085
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1842-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026