Class 2 Device Recall IQecg

• Date Initiated by Firm: May 18, 2010
• Date Posted: July 14, 2011
• Recall Status: Terminated on August 22, 2011
• Recall Number: Z-2726-2011
• Recall Event ID: 56016
• 510(K)Number: K955023
• Product Classification: Detector and alarm, arrhythmia - Product Code DSI
• Product: 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.
• Code Information: Software Version 8.0.1, 8.3, 8.3.1, 8.3.2
• Recalling Firm/ Manufacturer: Brentwood Medical Technology Corp; 1125 W 190th St; Gardena CA 90248-4303
• For Additional Information Contact: 310-516-6050 Ext. 5116
• Manufacturer 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
• FDA Determined 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: 1523 units
• Distribution: Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DSI and Original Applicant = BRENTWOOD MEDICAL PRODUCTS, INC.