Philips Ultrasound, Inc. Recall: Additional devices identified in new FSN MA-FCO 83000190:
Philips Ultrasound, Inc. Recall: Additional devices identified in new FSN MA-FCO 83000190: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Ultrasound, Inc.; Product: Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins inst
| Recalling firm | Philips Ultrasound, Inc. |
|---|---|
| Product | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products. |
| Reason for recall | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colo |
| Recall initiated | 20141105 |
| Recall number | Z-0815-2015 |
| Category | device |
| State | WA |
| Country | United States |
$29/mo
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