Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Moni
FDA device recall Z-0661-2016 · posted 2016-01-16 · Terminated
Recall details
- Recalling firm
- Fukuda Denshi USA, Inc.
- Reason for recall
- 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).
- Action taken
- Fukuda Denshi USA, Inc. of Redmond, WA plans to perform 100% field correction of units distributed in the US. The Recall/Field Correction Notice letter (FCN-A01-201512), dated December 21, 2015, and the Customer Confirmation Sheet will be sent to consignees using a clearly red-marked URGENT via Express Mail. The consignees are requested to fill out the Customer Confirmation Sheet and return via fax to 888-224-7090, email to DBlakely@fukuda.com, or send via postal service back to Fukuda Denshi USA, Inc. in a pre-stamped envelope. Consignee can call Doug Blakey directly at 210-240-4521 with any questions or concerns.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 95 units distributed in the US
- Distribution
- Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
- Date initiated
- 2015-12-21
- Date posted
- 2016-01-16
- Date terminated
- 2016-08-19
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR (K134046) | Fukuda Denshi USA, Inc. | 2015-02-12 |