Medical Device Recall: Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Spacelabs Healthcare, Inc. · November 25, 2024
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.
States Affected
AL, AR, CO, FL, GA, IA, ID, IL, KS, LA, MA, ME, MN, MO, MS, NM, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI
Quantity Affected
434
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0810-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.