Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Xhibit Telemetry Receiver with Software Recalled by Spacelabs Healthcare, Inc. Due to Telemetry receivers with affected software versions may experience...

Date: November 25, 2024
Company: Spacelabs Healthcare, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare, Inc. directly.

Affected Products

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

Quantity: 434

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 26 states: AL, AR, CO, FL, GA, ID, IL, IA, KS, LA, ME, MA, MN, MS, MO, NM, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI

Affected (26 states)Not affected

About Spacelabs Healthcare, Inc.

Spacelabs Healthcare, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report