Device recall
Z-0901-2015: SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40…
FDA device recall · Class II · Nonin Medical, Inc
Key facts
| Recall number (Z-number) | Z-0901-2015 |
|---|---|
| Recall event | 70045 |
| Product | SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then… |
| Product code | DQA |
| Recalling firm | Nonin Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2015 |
| 510(k) numbers | K132402 |
| FEI number | 2183646 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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