superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheo
FDA device recall Z-2001-2012 · posted 2012-07-12 · Terminated
Recall details
- Recalling firm
- superDimension, Inc
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OGK
- Quantity affected
- 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, Indi
- Date initiated
- 2012-06-18
- Date posted
- 2012-07-12
- Date terminated
- 2013-02-28
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUPERDIMENSION/BRONCHUS 4.1 (K052260) | Superdimension, Ltd. | 2005-09-08 |