# FDA recall Z-0810-2025

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

## Product

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

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0810-2025
- **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-0810-2025

## Citation

> AI Analytics. FDA recall Z-0810-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0810-2025. Source: US FDA. Licensed CC0.

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