Recall Z-1636-2008 ยท IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Chattanooga Corp Inc
VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.
| Date | Aug 6, 2008 (initiated Feb 28, 2008) |
| Status | Terminated |
| Reason | Device may fail to administer therapy during use. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 207 devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND Chattanooga Group, Dec 3, 2003 |