Nihon Kohden America Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Nihon Kohden America Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Nihon Kohden America Inc is recalling PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PS due to Medical device non-conformance to electrical safety standard (IEC 60601-1).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026