Recall Z-0203-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Fukuda Denshi Co., Ltd.
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, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pul
| Date | Oct 16, 2017 |
| Status | Completed |
| Reason | 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). |
| Root cause | Component design/selection |
| Action | The recalling firm will notify affected consignees via Field Correction Notification letter. The letter identified the affected product, problem and actions to be taken. A Customer Confirmation Sheet to be filled out by end user and faxed or emailed back to Fukuda Denshi USA, Inc will also be included. For questions call 206-305-4460. |
| Quantity | 6227 units |
| Distribution | Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries |
| 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 |