Device recall
Z-0289-04: Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery…
FDA device recall · Class II · Minolta Corp
Key facts
| Recall number (Z-number) | Z-0289-04 |
|---|---|
| Recall event | 27692 |
| Product | Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to… |
| Product code | DQA |
| Recalling firm | Minolta Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2004 |
| 510(k) numbers | K010413 |
| FEI number | 1000136179 |
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