Philips Ultrasound, Inc. Recall: EPIQ 7 Ultrasound System, EPIQ 7 systems with software ve
Philips Ultrasound, Inc. Recall: EPIQ 7 Ultrasound System, EPIQ 7 systems with software ve is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Ultrasound, Inc.; Product: EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-i
| Recalling firm | Philips Ultrasound, Inc. |
|---|---|
| Product | EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging. |
| 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-0817-2015 |
| Category | device |
| State | WA |
| Country | United States |
$29/mo
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