PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (
FDA device recall Z-0865-2021 · posted 2021-01-14 · Open, Classified
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- Medical device non-conformance to electrical safety standard (IEC 60601-1).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GWQ
- Quantity affected
- 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.
- Date initiated
- 2020-12-21
- Date posted
- 2021-01-14
- Location
- Foothill Ranch, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PSG-1100 SLEEP DIAGNOSTIC SYSTEM (K120888) | Nihon Kohden Corp. | 2012-11-09 |