Recall record at a glance
| Official record | Z-0661-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Fukuda Denshi USA, Inc. |
| Report date | Jan 27, 2016 |
| Recall initiation date | Dec 21, 2015 |
| Quantity | 95 units distributed in the US |
| Location | Redmond, WA, United States |
Official product description
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.
Why the product 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).
Distribution information
Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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