FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail
Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.
- Product
- Ultraview SL (UVSL) Command Module, Model 91496
- Category
- Medical Device
- Distribution
- Distributed nationwide