Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Reported: January 15, 2025 Initiated: November 25, 2024 #Z-0809-2025
Product Description
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Reason for Recall
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.
Details
- Recalling Firm
- Spacelabs Healthcare, Inc.
- Units Affected
- 2265
- Distribution
- 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
- Location
- Snoqualmie, WA
Frequently Asked Questions
What product was recalled? ▼
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.. Recalled by Spacelabs Healthcare, Inc.. Units affected: 2265.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2025. Severity: Moderate. Recall number: Z-0809-2025.
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