Company:Brentwood Medical Technology Corp
Date of Enforcement Report 8/3/11
Class ll:
PRODUCT
) IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2724-2011;
2) IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2725-2011;
3) IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2726-2011
REASON
The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient’s age. The software does this without notifying the user of the change from use of the Bazett equation, which is utilized for patients under the age of 16 years, to the use of the Hodges equation. If the user of the software does not access the QT dialogue box to accept or edit, then the QTc value for patients under 16 years of age is calculated from Bazett equation as expected. Midmark Diagnostic Group began shipping the software listed above on March 1, 2009. A copy of the shipping documents for the above referenced software is attached to aid you in identifying the software. The shipping documentation includes the part number(s) and date the software was shipped.
RECALLING FIRM/MANUFACTURER
Brentwood Medical Technology Corp., Gardena, CA, by letter on May 19, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1621 units
DISTRIBUTION
Nationwide and Internationally
