FDAFDA · Food and drugs·Recall number Z-1844-2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Published May 29, 2024 · Recall initiated: May 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.