Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors
Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the hazard involves a medical device that may display false physiological data (SpO2) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Spacelabs Healthcare, LLC is recalling the AriaTelemetry Transmitter, Model 96281, with SpO2 Option C. The recall involves 1,057 units, with 988 distributed in the United States and 69 outside the US. The devices are intended for use with adult or neonatal patient populations in a hospital environment.
The recall is being issued because the AriaTelemetry 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 defect could result in the display of inaccurate physiological data.
The affected units were distributed nationwide in the US, including in Arizona, California, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Puerto Rico. They were also distributed internationally to Canada, Chile, and Panama. Spacelabs is conducting an internal audit and has identified additional serial numbers for this recall.
The recalled product
- 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.
- Manufacturer
- Spacelabs Healthcare, Llc
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 (20)
- Serial Numbers IN the US: 6281- 002002
- 6281- 002003
- 6281- 002004
- 6281- 002005
- 6281- 002006
- 6281- 002007
- 6281- 002008
- 6281- 002009
- 6281- 002010
- 6281- 002011
- 6281- 002012
- 6281- 002013
- 6281-000295
- 6281-000401
- 6281-000402
- 6281-000403
- 6281-000404
- 6281-000405
- 6281-000406
- 6281-000407
Distribution
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