Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with centr...

FDA Device Recall #Z-2261-2020 — Class II — August 30, 2019

Recall Summary

Recall Number Z-2261-2020
Classification Class II — Moderate risk
Date Initiated August 30, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Spacelabs Healthcare, Inc.
Location Snoqualmie, WA
Product Type Devices
Quantity 2197 units

Product Description

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 Pattern

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

Lot / Code Information

Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345

Other Recalls from Spacelabs Healthcare, Inc.

Recall # Classification Product Date
Z-0169-2026 Class II Brand Name: Branding is not applied to this pro... Sep 5, 2025
Z-0168-2026 Class II Brand Name: Branding is not applied to this pro... Sep 5, 2025
Z-0167-2026 Class II Brand Name: Branding is not applied to this pro... Sep 5, 2025
Z-0809-2025 Class II Xhibit Telemetry Receiver, Model 96280, with Se... Nov 25, 2024
Z-0810-2025 Class II Xhibit Telemetry Receiver with Software, Model ... Nov 25, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.