# FDA recall Z-0809-2025

> **Spacelabs Healthcare, Inc.** · Class II · device recall initiated 2024-11-25.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-0809-2025
- **Recalling firm:** Spacelabs Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Snoqualmie, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2025

## Citation

> AI Analytics. FDA recall Z-0809-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0809-2025. Source: US FDA. Licensed CC0.

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