FDAOctober 16, 2017device
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, h...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
What to do
FDA enforcement status: Completed
Brands named
fukuda denshifukuda
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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