Boston Scientific Recalls LATITUDE Patient Management System Software
Boston Scientific is recalling the LATITUDE Patient Management System software because a system update caused clinic faxes to display illegible characters instead of required patient information.
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 a software defect resulting in illegible data and missing information, which is a functional failure rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Boston Scientific CRM Corp is conducting a recall of the LATITUDE Patient Management System, Model 6488, Version 7.3. This software is intended to remotely communicate with compatible Boston Scientific pulse generators and transfer data to a central database.
The recall was initiated because a Siebel release between March 4 and 27, 2013, caused approximately 5,000 distributed PMR clinic faxes to display with illegible characters. Consequently, these faxes did not display the required patient non-compliance information that was intended to be shown.
The affected units were distributed nationwide, including the District of Columbia and Puerto Rico. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
- Manufacturer
- Boston Scientific CRM Corp
- Category
- Medical Device — Software
- Affected units
- 1
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)
- n/a
Distribution
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