Nihon Kohden America Inc: Medical Device Recall in 2021 - (Recall #: Z-0865-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 21, 2020

Date Posted: February 3, 2021

Recall Number: Z-0865-2021

Event ID: 87011

Reason for Recall:

Medical device non-conformance to electrical safety standard (IEC 60601-1).

Status: Ongoing

Product Quantity: 189 Units

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated