ARIATELE TELEMETRY TRANSMITTER — Class II medical device recall Z-2586-2014
Terminated recall by Spacelabs Healthcare Inc, reported 2014-09-10, distributed in TX. The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not
| Recall number | Z-2586-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2014-07-02 |
| Classified | 2014-09-04 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2014-10-16 |
| Distributed | TX |
| Quantity | 8 units |
| Serial numbers | 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, 6281-003056 |
| Model numbers | 96281 |
Product
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Reason for recall
The 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. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2586-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.