Superdimension, Ltd.
Country not established
- Devices
- 12
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Superdimension, Ltd. makes
Superdimension, Ltd. manufactures bronchoscopy planning and navigation systems, including the INREACH System and its variants (e.g., I-Logic INREACH System, Model AAS00161-02) for real-time airway visualization and procedural guidance. The company also produces the Superdimension/Bronchus series (e.g., Superdimension/Bronchus Premium, Premium 2, and 4.1) for bronchoscopic interventions, alongside a dedicated INREACH Planning Laptop for pre-procedural mapping.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States, with all listed products registered in the FDA’s 510(k) database.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 3 recalls initiated by Superdimension, Ltd., the earliest on 2006-11-29 and the most recent on 2012-06-18. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 18 Jun 2012 Z-2001-2012 Class II Terminated 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
Full distribution text
- 18 Jun 2012 Z-2001-2012 Class II Terminated 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
2006
- 29 Nov 2006 Z-0666-2007 Unclassified (pre-2012) Terminated The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
Full distribution text
- 29 Nov 2006 Z-0667-2007 Unclassified (pre-2012) Terminated The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
Full distribution text
- 29 Nov 2006 Z-0666-2007 Unclassified (pre-2012) Terminated The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
Frequently asked questions
How many devices does Superdimension, Ltd. have in the registry?
The registry currently lists 12 devices for Superdimension, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Superdimension, Ltd.'s devices?
Among its 12 most recently registered devices, Superdimension, Ltd. has devices listed in FDA 510(k) (12 devices).
What risk classes do Superdimension, Ltd.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Superdimension, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Superdimension, Ltd.?
FDA recall records list 3 recalls initiated by Superdimension, Ltd., the most recent initiated on 18 Jun 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Superdimension, Ltd. in the registry?
The most recently registered devices listed for Superdimension, Ltd. include SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER, INREACH SYSTEM, SUPERDIMENSION/BRONCHUS PREMIUM and SUPERDIMENSION MARKER DELIVERY KIT.