Class II — Spacelabs Healthcare, Llc
| Recalling firm | SPACELABS HEALTHCARE, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. |
| Product | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. |
| Quantity | 1057 units (988 in the US and 69 outside of the US). |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama. |
| Initiated | 2013-12-19 |
| Classified | 2014-01-30 |
| Terminated | 2014-06-12 |
| Recall number | Z-0871-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spacelabs Healthcare, Llc (Z-0871-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67243/
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