Boston Scientific Recalls iLab Polaris Systems Due to Data Archiving Bug
Boston Scientific is recalling 150 iLab Polaris and Ultrasound systems in Europe because a software bug prevents specific data from being archived without notifying the user.
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, but the hazard is a software data integrity issue (loss of diagnostic data) rather than a direct physical injury or life-threatening malfunction. No injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 150 units of the iLab Polaris Multi-Modality Guidance System and iLab Ultrasound Imaging System. The affected units were upgraded with a specific version of 2.10 software (disk batch 629774) that contains a bug affecting data storage.
The defect causes the system to fail to archive Diastolic Hyperemia-Free Ratio (DFR) data if the user selects Multi-Frame UltraSound or SC Image Storage formats. When this occurs, the system does not notify the user of the failure, meaning the data is lost without warning. The issue only allows data to be archived correctly if the True Color Secondary Capture format is used.
The recall affects units distributed to Japan, Belgium, Denmark, France, Great Britain, and Spain. There are no U.S. consignees for this recall. Users should check their software version and serial numbers against the provided list to determine if their system is affected.
The recalled product
- Product
- iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 150
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)
- Polaris 2.10 software version (disk batch 629774)
- iLab Polaris Systems affected product listing (serial numbers): 200204
- 200209
- 200217
- 200308
- 200310
- 200448
- 200450
- 200456
- 200457
- 200458
- 200461
- 200480
- 200481
- 200103
- 200145
- 200044
- 200118
- 200360
- 200498
Distribution
Distribution scope not specified by the agency.
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