Z-0865-2021Class II

PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head...

Name: Z-0865-2021 PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head...
Creator: Nihon Kohden America Inc
Published: 2020-12-21
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2020-12-21 / Open, Classified / root cause: design

FDA source

Nihon Kohden America Inc began a recall of 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... on 2020-12-21. FDA classified it as Class II and gives the reason as "Medical device non-conformance to electrical safety standard (IEC 60601-1)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0865-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-21
Posted: 2021-01-14
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.
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Medical device non-conformance to electrical safety standard (IEC 60601-1).
Root cause tag: design
FDA 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: [email protected] or [email protected]. If you have any questions, please call the Toll-free: 1-800-325-0283, Option 6 (Monday-Friday,8am-5pm PDT) or E-mail: [email protected] or [email protected].
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0865-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-14

Product code GWQ

K120888Class IIPsg-1100 Sleep Diagnostic SystemNihon Kohden Corp. / cleared 2012-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)