Z-0661-2016 Class II Terminated
FDA device recall Z-0661-2016 was initiated by Fukuda Denshi USA, Inc. on December 21, 2015 and is designated Class II. 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). The recall status is terminated (terminated August 19, 2016). Affected quantity: 95 units distributed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- December 21, 2015
- Termination Date
- August 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 units distributed in the US
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).
Distribution Pattern
Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
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.