Boston Scientific LATITUDE Programming System Software Update Recall
Boston Scientific is recalling four LATITUDE Programming System devices that downloaded unapproved software applications.
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling four LATITUDE Programming System, Model 3300 devices. These devices are intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems.
The recall was initiated because a new Software Update Application was downloaded to the four distributed programmers. This application directed the devices to download software applications that have not been approved by the US Food and Drug Administration.
The affected devices were distributed in the United States in the states of North Carolina, Tennessee, and Missouri. The specific serial numbers for the recalled units are 008885, 010823, 010615, and 007886. Users should contact Boston Scientific for further instructions regarding the software update.
The recalled product
- Product
- Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4
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 (4)
- Serial Numbers: 008885
- 010823
- 010615
- 007886
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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