Edwards HemoSphere System Recalled for Pre-Procedural Software Defects
Edwards Lifesciences is recalling 198 HemoSphere System devices due to pre-procedural software defects. The devices are distributed in 11 US states.
- Product
- Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards…
- Category
- Medical Device
- Distribution
- Distributed nationwide