Drug recall
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of…
FDA recall event 62381 · Class II · superDimension, Inc
Key facts
| Event ID | 62381 |
|---|---|
| Recall numbers | Z-2001-2012 |
| Recalling firm | superDimension, Inc |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jun 18, 2012 |
| Report date | Jul 18, 2012 |
| Termination date | Feb 28, 2013 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3004962788 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: