PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Complian...
FDA Recall #Z-0865-2021 — Class II — December 21, 2020
Product Description
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
Reason for Recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Recalling Firm
Nihon Kohden America Inc — Foothill Ranch, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
189 Units
Distribution
US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.
Code Information
Serial numbers 3. Serial numbers 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358 -1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507- 1516.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated