Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use Recalled by superDimension, Inc Due to superDimension, Inc., is conducting a recall of certain...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact superDimension, Inc directly.
Affected Products
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. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
Quantity: 99
Why Was This Recalled?
superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About superDimension, Inc
superDimension, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report