Z-0810-2025 Class II Ongoing
FDA device recall Z-0810-2025 was initiated by Spacelabs Healthcare, Inc. on November 25, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 434.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- November 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 434
Product Description
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
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.
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.
Code Information
Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246