Reported Jan 27, 2016 · Terminated
Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient…
Fukuda Denshi USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fukuda Denshi USA, Inc. · 17725 NE 65th St Ste C · Redmond, WA · 98052-4911
Is this the product you have?
- Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
- Lot codes and dates
95 of 95 codes
504000015040000250400003504000045040001150400012504000185040001950400020504000215040002250400023504000245040002550400026504000275040002850400029504000305040003150400032504000335040003450400035504000365040003750400038504000395040004050400042504000435040004450400045504000465040004750400048504000495040005050400051504000525040005350400054504000555040005650400057504000585040005950400060504000615040006250400063504000645040006550400066504000675040006850400069504000705040007150400072
- Amount recalled
- 95 units distributed in the US
Where it was sold
Why it was recalled
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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