Spacelabs Ariatele Telemetry Transmitter Recalled for SpO2 Display Errors
Spacelabs is recalling Ariatele Telemetry Transmitters because they may display SpO2 values when sensors are disconnected or failed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incorrect physiological data) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Spacelabs Healthcare Inc is recalling Ariatele Telemetry Transmitters, Model 96281, with SpO2 Option C. These physiological patient monitors are used in hospital environments. The recall involves 8 units distributed to Texas.
The recall is being conducted because 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 action is an expansion of recall Z-0871-2014, as additional serial numbers were identified during the firm's retrospective analysis of recalls since 2011.
The affected serial numbers are 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Healthcare facilities should contact Spacelabs Healthcare Inc for further instructions regarding the recall.
The recalled product
- Product
- ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Serial numbers: 6281-002500
- 6281-002501
- 6281-002659
- 6281-002661
- 6281-002662
- 6281-002663
- 6281-002664
- and 6281-003056. Model 96281
- with SpO2 Option C.
Distribution
Distributed in 1 state:
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