Recall Z-2725-2011 ยท DSI Detector And Alarm, Arrhythmia
Brentwood Medical Technology Corp
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.
| Date | Jul 14, 2011 (initiated May 18, 2010) |
| Status | Terminated |
| 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 utiliz |
| 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 |
| Quantity | 8 units |
| Distribution | Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955023 | BRENTWOOD PC-ECG Brentwood Medical Products, Inc., Jan 22, 1997 |