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Recall Observatory FDA recall evidence

Device product

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

Z-0810-2025

November 25, 2024

Class II

Product summary

Firm
Spacelabs Healthcare, Inc.
Event
Event 95910
Status
Ongoing
Classification
Class II
Quantity
434
Official record key
device-enforcement:Z-0810-2025

Official wording

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.

Code information: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions may