Class 2 Device Recall superDimension Systems

• Date Initiated by Firm: June 18, 2012
• Date Posted: July 12, 2012
• Recall Status: Terminated on February 28, 2013
• Recall Number: Z-2001-2012
• Recall Event ID: 62381
• 510(K)Number: K052260
• Product Classification: Orotrachael intubation guide kit - Product Code OGK
• 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.
• 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
• Recalling Firm/ Manufacturer: superDimension, Inc; 161 Cheshire Ln N Ste 100; Minneapolis MN 55441-5433
• For Additional Information Contact: 763-210-4000
• Manufacturer 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
• FDA Determined Cause: Device Design
• Action: superDimension sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advised customers to discontinue use of the system and requested consignees to complete and return the acknowledgement receipt form via fax to 763-210-4098. Contact the firm at 763-210-4057 for questions regarding this recall.
• Quantity in Commerce: 99
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OGK and Original Applicant = SUPERDIMENSION, LTD.