Device recall
Z-0865-2021: PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454…
FDA device recall · Class II · Nihon Kohden America Inc
Key facts
| Recall number (Z-number) | Z-0865-2021 |
|---|---|
| Recall event | 87011 |
| 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… |
| Product code | GWQ |
| Recalling firm | Nihon Kohden America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K120888 |
| FEI number | 2080783 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database