superDimension Systems AAS00016-xx with Software Version 4 — Class II medical device recall Z-2001-2012
Terminated recall by superDimension, Inc, reported 2012-07-18, distributed nationwide. superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0
| Recall number | Z-2001-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | superDimension, Inc, Minneapolis, MN, United States |
| Recall initiated | 2012-06-18 |
| Classified | 2012-07-12 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FR, GB, HU, IT, MX, NL, TR, ZA |
| Quantity | 99 |
| Reason classes | device malfunction, software |
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. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2001-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.