Spacelabs Sentinel V10 and V11 Software Upgrade Recall
Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.
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. The hazard involves incorrect data entry (comments) on medical tests, which is a data integrity issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for minor labeling or data errors.
Plain-English summary
Spacelabs Healthcare, Ltd. is recalling Sentinel V10.x and V11.x software, Models 98200 and 98201. The recall involves 600 units distributed worldwide and across the United States. The software is designed using the latest programming technology and is easy to install and use.
The recall is due to a software defect where incorrect comments may be added to existing tests during a system upgrade. Specifically, Resting ECG and ABP tests that did not contain comments at the time of the upgrade may have unrelated comments added. Additionally, Rhythm ECG Tests may have comments overwritten with unrelated comments. Existing comments are not overwritten or removed, and any tests created after the upgrade are not affected.
This recall affects systems that have been upgraded from Version 9 or below to Version 10 or above. The source text does not specify specific actions for consumers or healthcare providers beyond the description of the defect.
The recalled product
- Product
- Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Category
- Medical Device — Software
- Affected units
- 600
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 (1)
- Systems that have been upgraded from Version 9 or below to Version 10 or above.
Distribution
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