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
- Recall Number
- Z-0865-2021
- Event Number
- 87011
- Firm
- Nihon Kohden America Inc
- FEI Number
- 2080783
- Product Code
- GWQ
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 21, 2020
- Posted
- January 14, 2021
- Address
- 90 Icon, Foothill Ranch, CA, 92610-3000
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.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
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].
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.
189 Units