FDA-Device2025-01-15Class II
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Spacelabs Healthcare, Inc.
Hazard
Telemetry receiver systems may experience a Windows proxy Issue causing the system to 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; necessary clinical intervention could be delayed.
Sold states
US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech Republic
Affected count
2265
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2025Don't want to check this manually?
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