Spacelabs Healthcare, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0810-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 25, 2024

Date Posted: January 15, 2025

Recall Number: Z-0810-2025

Event ID: 95910

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 434

Code Information:

Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246

Distribution Pattern:

US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.

Voluntary or Mandated:

Voluntary: Firm initiated