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.
FDA Recall Z-0865-2021 · Posted 2021-01-14
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Recalling FirmNihon Kohden America Inc
Recall StatusOpen, Classified
Product CodeGWQ
Date Initiated2020-12-21
Product Quantity189 Units
Reason for Recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Firm 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].
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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