Spacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure
Spacelabs Healthcare is recalling 89 elance Vital Signs Monitors because they cannot connect to Spacelabs TruLink SpO2 sensors.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a functional limitation (inability to connect specific sensors) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Spacelabs Healthcare, LLC is recalling 89 units of the elance Vital Signs Monitor, Model 93300, with Option S. The recall affects one unit in the United States and 88 units distributed internationally in Puerto Rico, France, Indonesia, Korea, Nicaragua, the Philippines, and Taiwan.
The recall is being issued because the monitors will not permit the connection of any Spacelabs TruLink line of SpO2 sensors. This defect prevents the use of specific pulse oximetry sensors with the affected devices.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Spacelabs Healthcare is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
- Manufacturer
- Spacelabs Healthcare, Llc
- Category
- Medical Device — Patient Monitor
- Hazard
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)
- 3300-203362
- 3300-203363
- 3300-203364
- 3300-203386
- 3300-203387
- 3300-203388
- 3300-203389
- 3300-203390
- 3300-203391
- 3300-203392
- 3300-203393
- 3300-203394
- 3300-203395
- 3300-203396
- 3300-203397
- 3300-203398
- 3300-203399
- 3300-203400
- 3300-203401
- 3300-203402
Distribution
Distributed in 1 state:
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