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.
This recall is currently active, issued January 14, 2021. It was issued by Nihon Kohden America Inc.
- Company
- Nihon Kohden America Inc
- Recall Initiated
- December 21, 2020
- Posted
- January 14, 2021
- Recall Number
- Z-0865-2021
- Quantity
- 189 Units
- Firm Location
- Foothill Ranch, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
On 12/21/2020, the firm , Nihon Kohden, sent out an "URGENT RECALL NOTIFICATION" letter dated 12/21/2020 to all affected consumers . The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number (949) 580-1550 or email it to: JB110@NKUSA.com or JB110@nihonkohden.com. If you have any questions, please call the Toll-free: 1-800-325-0283, Option 6 (Monday-Friday,8am-5pm PDT) or E-mail: JB110@NKUSA.com or JB110@nihonkohden.com.