Spacelabs Healthcare, Inc.: Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

Hazard

Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

Details from the source

Reason for recall: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed. Distribution: US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland. Quantity: 434 Lot/code info: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246

UPC codes

10841522107177, 10841522100246

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.