Recall Z-0661-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Fukuda Denshi USA, Inc.
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.
| Date | Jan 16, 2016 (initiated Dec 21, 2015) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Process control |
| Action | 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 a |
| Quantity | 95 units distributed in the US |
| Distribution | Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR Fukuda Denshi USA, Inc., Feb 12, 2015 |