superDimension Systems Software Recall Due to Locatable Guide Malfunction
superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the malfunction of a medical imaging system used to guide tools in the pulmonary tract poses a risk of harm, though no specific injuries are reported in the text.
Plain-English summary
superDimension, Inc. is conducting a recall of superDimension Systems operating Software Version 4.0 through 4.9. The affected systems are identified by the product code AAS00016-xx. These systems are indicated for displaying images of the tracheobronchial tree to aid physicians in guiding endoscopic tools or catheters in the pulmonary tract and for marker placement within soft lung tissue. The devices are not for pediatric use.
The recall is being conducted because the affected systems have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, systems using Software Version 4.0-4.9 will not recognize the Locatable Guide.
The recall involves 99 units distributed worldwide, including the United States (nationwide, including Puerto Rico) and various international locations such as Canada, Australia, and several European and Middle Eastern countries. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue.…
- Manufacturer
- superDimension, Inc
- Affected units
- 99
Distribution
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