Device recall
Z-0821-06: CALM software, version 02.09.01 This software is intended for use as a central…
FDA device recall · Class II · LMS Medical Systems Ltd
Key facts
| Recall number (Z-number) | Z-0821-06 |
|---|---|
| Recall event | 35138 |
| Product | CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress… |
| Product code | HGM |
| Recalling firm | LMS Medical Systems Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2006 |
| FEI number | 3002687025 |
At a glance
- None 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