CS100 IABP. Software Version CS100 IABP Q.01.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 23, 2026 |
| Reported | March 11, 2026 |
| Recalling firm | Datascope Corp. |
| Country / region | United States NJ |
Hazard
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Affected products
- CS100 IABP. Software Version CS100 IABP Q.01.
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