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Terminated

VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.

FDA Recall Z-1636-2008 · Posted 2008-08-06

Recalling FirmChattanooga Corp Inc
Recall StatusTerminated
Product CodeIMI
Date Initiated2008-02-28
Date Terminated2010-02-19
Product Quantity207 devices

Reason for Recall

Device may fail to administer therapy during use.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031116VECTRA (INTELECT) EPR ULTRASOUNDChattanooga Group · 2003-12-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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