FDA Enforcement
Class II
Ongoing
Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
Recall: Z-1840-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1840-2024
- Event ID
- 94508
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 29, 2024
- Initiation Date
- May 3, 2024
- Classification Date
- May 17, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
Description
Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
Reason
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
Code Info
UDI-DI: N/A Serial Numbers: 43006
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.
Quantity
1 unit