Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

Recall date

November 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0809-2025

FDA classification

Class II

Brand / firm

Spacelabs Healthcare, Inc.

Sold / distributed

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, Ne…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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