Recall Z-0865-2021 ยท GWQ Full-Montage Standard Electroencephalograph
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.
| Date | Jan 14, 2021 (initiated Dec 21, 2020) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM Nihon Kohden Corp., Nov 9, 2012 |