Fukuda Denshi patient monitor recall
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…
Why was Fukuda Denshi patient monitor recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all DS-8100 units manufactured and distributed worldwide.
- Product
- 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…
- Recalling firm
- Fukuda Denshi Co., Ltd.
- Quantity
- 6227 units
- Distribution
- Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries
- Recall date
- December 13, 2017
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)