# FDA recall Z-0532-2018

> **Spacelabs Healthcare Inc** · Class II · device recall initiated 2018-01-17.

## Product

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms)    The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

## Reason for recall

Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

## Distribution

US Distribution to the states of : VA, NJ, MI, GA, and Internationally to  France

## Key facts

- **Recall number:** Z-0532-2018
- **Recalling firm:** Spacelabs Healthcare Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-17
- **Report date:** 2018-02-14
- **Termination date:** 2018-11-29

- **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-0532-2018

## Citation

> AI Analytics. FDA recall Z-0532-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0532-2018. Source: US FDA. Licensed CC0.

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