FDA-Device2025-11-19Class II
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
GE Healthcare Finland Oy
Hazard
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Sold states
Worldwide - US Nationwide distribution.
Affected count
5990
Manufactured in
Kuortaneenkatu 2, Helsinki, Finland
Products
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0456-2026Don't want to check this manually?
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