FDA Medical Device Recalls (openFDA)
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 number
- Z-0865-2021
- Recalling firm
- Nihon Kohden America Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2020-12-21
- Posted
- 2021-01-14
- Terminated
- not on file
- Reason
- Medical device non-conformance to electrical safety standard (IEC 60601-1).
- Root cause
- Device Design
- Action
- 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.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K120888"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 2080783
- Firm city
- Foothill Ranch
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28