Company: Spacelabs Healthcare, Inc.
Date of Enforcement Report: 1/07/2025
Class II
PRODUCT
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Recall Number:
Z-0810-2025
REASON:
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
RECALLING FIRM/MANUFACTURER:
Spacelabs Healthcare, Inc.
VOLUME OF PRODUCT IN COMMERCE:
434
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.
