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.
Related recalls
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER