FDA Medical devices recall · January 15, 2025

Xhibit Telemetry Receiver with Software, Model 96280… recall

Read the official FDA notice ↗

Product

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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

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.

States: Alabama Arkansas Colorado Florida Georgia Iowa Idaho Illinois Kansas Louisiana Massachusetts Maine Minnesota Missouri Mississippi New Mexico New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Washington Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0810-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.