Boston Scientific Recalls iLab Ultrasound Systems Due to Measurement Error
Boston Scientific is recalling 9 iLab Ultrasound Imaging Systems because a software update may cause the Longview distance measurement to display double the actual value.
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 hazard involves inaccurate measurement data rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Boston Scientific Corporation is recalling 9 units of the iLab Ultrasound Imaging System equipped with iLab 3.0 (Polaris 1.0) software. These devices are used for ultrasound examinations of intravascular pathology. The recall affects specific units distributed nationwide in New York, North Carolina, Washington D.C., Florida, and Pennsylvania.
The recall is issued because the newest 3.0 (Polaris 1.0) software changes the default pullback speed from 0.5 mm/sec to 1.0 mm/sec. This change may cause the Longview distance measurement to display an inaccurate value that is double the actual distance. The affected units have specific model numbers and serial numbers listed in the recall documentation.
Healthcare facilities and users should stop using the affected iLab Ultrasound Imaging Systems and contact Boston Scientific Corporation for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 9
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 (5)
- 4900
- 5701
- 5827 7516
- 7517
- 7607 8407
Distribution
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