FDA-Device2024-05-29Class II
Achieva 3.0T TX for PET Model Number (REF): 781479
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
Sold states
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.
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Achieva 3.0T TX for PET Model Number (REF): 781479
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1841-2024More Philips North America Llc recalls
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon Fetal Monitor FM 30 recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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