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U.S. Department of Health and Human Services

Class 2 Device Recall Fukuda Denshi patient monitor

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  Class 2 Device Recall Fukuda Denshi patient monitor see related information
Date Initiated by Firm December 21, 2015
Date Posted January 16, 2016
Recall Status1 Terminated 3 on August 19, 2016
Recall Number Z-0661-2016
Recall Event ID 72953
510(K)Number K134046  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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.
Code Information 50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.
Recalling Firm/
Manufacturer		 Fukuda Denshi USA, Inc.
17725 NE 65th St Ste C
Redmond WA 98052-4911
For Additional Information Contact
210-240-4521
Manufacturer 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).
FDA Determined
Cause 2		 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 any questions or concerns.
Quantity in Commerce 95 units distributed in the US
Distribution Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = FUKUDA DENSHI USA, INC.
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