Recall archive / FDA device enforcement
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. — FDA record Z-0810-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 434
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0810-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 15, 2025
- Recall initiation date
- Nov 25, 2024
- Center classification date
- Jan 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.