Z-1844-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-1844-2024 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.

Recall Details

Product Type
Devices
Report Date
May 29, 2024
Initiation Date
May 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated

Product Description

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

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: 42246 85713 42029 71774 85668 85680 85685 85694 85705 42023 42024 42375 42217 42402 71044 85698 85700 85146 85677 85699 71595 71815 85649 42320 85684 71836 85679 85682 85697 85701 85708 85714

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1844-2024
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.