Boston Scientific Recalls EXALT Controllers Due to Suboptimal Brightness Settings
Boston Scientific is recalling three EXALT Controllers because they may have been programmed with suboptimal brightness settings, resulting in darker than desired images.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates the product is unlikely to cause adverse health consequences. The issue is a suboptimal brightness setting affecting image quality, not a direct safety hazard.
Plain-English summary
Boston Scientific Corporation is recalling three units of the EXALT Controller. This device is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. The recall is due to a programming issue where the devices may have been set to a less than optimal brightness level, which can result in a darker than desired image during use.
The affected units were distributed nationwide in the United States, specifically in the states of California, Florida, and New Jersey. The specific serial numbers for the recalled units are 2005201213, 2005201287, and 2005201346. The Global Trade Item Number (GTIN) for the product is 08714729990901.
Healthcare facilities and users should check their inventory for these specific serial numbers. If the devices are found, they should be removed from service and returned to Boston Scientific Corporation in accordance with the recall instructions.
The recalled product
- Product
- EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 3
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)
- Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Distribution
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