Recall Z-0661-2016— Fukuda Denshi USA, Inc.

Name: FDA recall Z-0661-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-21

Class II · Terminated

Class II FDA medical device recall by Fukuda Denshi USA, Inc., initiated 2015-12-21, terminated 2016-08-19. It names one FDA 510(k) clearance: K134046. Product: 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.. 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)..

Recalling firm: Fukuda Denshi USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Terminated: 2016-08-19
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITORFukuda Denshi USA, Inc.·cleared 2015-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.