Official recall notice
FDA DeviceClass IINotable
FDA Recall: CS300 IABP. Software Version CS300 IABP C.01.
- Recall date
- 2026-03-11
- Brand
- Datascope Corp.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Recommended action
What to do
10,897 units
Product description
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.