Recall Z-2001-2012 ยท OGK Orotracheal Intubation Guide Kit
superDimension, Inc
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.
| Date | Jul 12, 2012 (initiated Jun 18, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root 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 | 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, Mississ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052260 | SUPERDIMENSION/BRONCHUS 4.1 Superdimension, Ltd., Sep 8, 2005 |