superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displa...
FDA Device Recall #Z-2001-2012 — Class II — June 18, 2012
Recall Summary
| Recall Number | Z-2001-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 18, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | superDimension, Inc |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 99 |
Product Description
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
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
Lot / Code Information
S030097 S0030044 S030065 S030092 S030579 S420011 S420102 I4202008 S0030045 S030066 S030092 S030586 S420012 S420105 I4202012 S00312 S030067 S030094 S030587 S420013 S420107 S0030011 S030043 S030069 S030096 S030588 S420015 S420108 S0030013 S030046 S030070 S030098 S030604 S420019 S420109 S0030014 S030049 S030072 S030099 S030605 S420020 S420110 S0030015 S030052 S030075 S030102 S030608 S420021 S420112 S0030017 S030054 S030076 S030105 S030609 S420026 S420114 S0030021 S030056 S030077 S030449 S300049 S420036 S420125 S0030022 S030057 S030080 S030477 S300082 S420037 S830001 S0030023 S030058 S030081 S030492 S310078 S420077 S0030024 S030059 S030083 S030541 S310100 S420079 S0030025 S030060 S030085 S030546 S420006 S420080 S0030026 S030061 S030087 S030547 S420008 S420092 S0030042 S030064 S030089 S030573 S420009 S420100
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.