Recall Z-0095-2019 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient
| Date | Sep 4, 2018 |
| Status | Open, Classified |
| Reason | When multiple CARESCAPEMonitor B450 or B850 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 issued the Medical Device Correction Notice on 09/04/2018 by letter. The letter explained the issue and provided the following safety instructions: If a prolonged network overload occurs and CARESCAPE Monitor Bx50 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 con |
| Quantity | 59,000 units |
| Distribution | Worldwide Distribution-US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132533 | CARESCAPE MONITOR B450 GE Healthcare Finland Oy, Dec 4, 2013 |