Reported Jul 18, 2012 · Terminated
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the…
superDimension, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: superDimension, Inc · 161 Cheshire Ln N Ste 100 · Minneapolis, MN · 55441-5433
Is this the product you have?
- 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.
- Lot codes and dates
100 of 100 codes
S030097S0030044S030065S030092S030579S420011S420102I4202008S0030045S030066S030092S030586S420012S420105I4202012S00312S030067S030094S030587S420013S420107S0030011S030043S030069S030096S030588S420015S420108S0030013S030046S030070S030098S030604S420019S420109S0030014S030049S030072S030099S030605S420020S420110S0030015S030052S030075S030102S030608S420021S420112S0030017S030054S030076S030105S030609S420026S420114S0030021S030056S030077S030449
- Amount recalled
- 99
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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