Z-2724-2011

IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the...

Name: Z-2724-2011 IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the...
Creator: Brentwood Medical Technology Corp
Published: 2010-05-18
License: https://open.fda.gov/license/

Brentwood Medical Technology Corp. / initiated 2010-05-18 / Terminated / root cause: software

FDA source

Brentwood Medical Technology Corp began a recall of 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... on 2010-05-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2724-2011
Status: Terminated
Initiated: 2010-05-18
Posted: 2011-07-14
Terminated: 2011-08-22
Recalling firm: Brentwood Medical Technology Corp.
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.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: 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 utiliz
Root cause tag: software
FDA root cause: Software design
Action: The firm, Midmark, sent an "URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter on May 19, 2010 with an attached Corrective Return Material Authorization (RMA) form via US Postal Service Certified Mail to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their IQecg, IQmanager, or lQiC Centricity software to determine the software version currently in use. If it is a listed product, it is subject to this field corrective action. A sample software label was attached to aid the consignees/customers in locating and identifying the software CD. For customers who have already installed the software, the version number can be identified in the "About" page. Consignees/customers were instructed to complete the enclosed Field RMA form and return it with the affected software to: Quality Assurance Department Midmark Diagnostics Group 1125 West 190 S t. Gardena, CA 90248 In addition, if they further distributed this product, identify customers and notify them at once of this product field corrective action. Replacement software was to be shipped to the consignees/customers upon receipt of the returned software CD. If they require a UPS return shipping label or an on-line download of replacement software, contact Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or 5108. If you have any questions, call Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or QA/RA Manager, Midmark Diagnostics Group 310-516-5116.
Quantity in commerce: 90 units
Distribution: Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia.
Product codes and lots: Software Version 6.0

Product code DSI

K955023Class IIBrentwood Pc-ECGBrentwood Medical Products, Inc. / cleared 1997-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)