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U.S. Department of Health and Human Services

Class 2 Device Recall PSG1100 Sleep Diagnostic System.

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  Class 2 Device Recall PSG1100 Sleep Diagnostic System. see related information
Date Initiated by Firm December 21, 2020
Date Posted January 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0865-2021
Recall Event ID 87011
510(K)Number K120888  
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
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.
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. 
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
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Foothill Ranch CA 92610-3000
For Additional Information Contact Nihon Kohden America Technical Services Group
800-325-0283
Manufacturer Reason
for Recall		 Medical device non-conformance to electrical safety standard (IEC 60601-1).
FDA Determined
Cause 2		 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 or JB110@nihonkohden.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = NIHON KOHDEN CORP.
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