# FDA recall Z-1513-2022

> **Spacelabs Healthcare, Inc.** · Class II · device recall initiated 2022-05-31.

## Product

Xhibit Telemetry Receiver, Model: 96280

## Reason for recall

Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.

## Key facts

- **Recall number:** Z-1513-2022
- **Recalling firm:** Spacelabs Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-31
- **Report date:** 2022-08-17

- **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-1513-2022

## Citation

> AI Analytics. FDA recall Z-1513-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1513-2022. Source: US FDA. Licensed CC0.

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