PlainRecalls
FDA Devices Moderate Class II Ongoing

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

Reported: May 29, 2024 Initiated: May 3, 2024 #Z-1839-2024

Product Description

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

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

Details

Recalling Firm
Philips North America Llc
Units Affected
386 units
Distribution
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.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177. Recalled by Philips North America Llc. Units affected: 386 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1839-2024.