# FDA recall Z-2261-2020

> **Spacelabs Healthcare, Inc.** · Class II · device recall initiated 2019-08-30.

## Product

Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

## Reason for recall

The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

## Distribution

Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.

## Key facts

- **Recall number:** Z-2261-2020
- **Recalling firm:** Spacelabs Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-30
- **Report date:** 2020-06-10
- **Termination date:** 2024-04-18

- **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-2261-2020

## Citation

> AI Analytics. FDA recall Z-2261-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2261-2020. Source: US FDA. Licensed CC0.

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