INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chat
FDA device recall Z-1637-2008 · posted 2008-08-06 · Terminated
Recall details
- Recalling firm
- Chattanooga Corp Inc
- Reason for recall
- Device may fail to administer therapy during use.
- Action taken
- Chattanooga Group sent an Urgent Medical Device Recall letter dated 02/29/2008 to consignees to advise them of problem and the recall. The first group of letters was sent to the distributors via certified mail. The letter stated that the devices were failing and the recall was to the User level. The firm is recalling the devices for repair and calibration. The firm followed with a user notification, by US Mail not certified beginning on March 11, 2008.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IMG
- Quantity affected
- 369 devices
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-02-28
- Date posted
- 2008-08-06
- Date terminated
- 2010-02-19
- Location
- Hixson, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (K031077) | Chattanooga Group | 2003-12-11 |