Recall Z-2340-2018 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B650
| Date | May 25, 2018 |
| Status | Open, Classified |
| Reason | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected. |
| Root cause | Software design |
| Action | The firm notified its consignees of the problem by letter on 05/25/2018. The letter stated the following safety instructions: "If a prolonged network overload occurs and CARESCAPE Monitor B650 on the network does not resume normal functionality in approximately 90 seconds, take the following actions: 1. Temporarily switch the monitor from central monitoring to local-only (bedside) monitoring: - Disconnect the LAN cables from IX/MC ports on backside of the monitor. The monitor will now be in local-only mode. - Keep the patient under close observation and continuous surveillance at t |
| Quantity | 69231 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |