FDA recall Z-0865-2021

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.

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.

Key facts

Status

Ongoing

Initiation date

2020-12-21

Report date

2021-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2021