FDA Device recall Z-0817-2015
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
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of 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 by Philips Ultrasound, citing 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 V….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0817-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-05 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Ultrasound |
| Distribution | 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, WI |
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
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.
Identifiers
| code_info | SERIAL NUMBERS FOR FCO 079500318- EPIQ 7 SYSTEM: US114B0038, US114B0040, US114B0055, US114B0091, US114B0111, US114B0…SERIAL NUMBERS FOR FCO 079500318- EPIQ 7 SYSTEM: US114B0038, US114B0040, US114B0055, US114B0091, US114B0111, US114B0112, US114B0113, US114B0114, US114B0115, US114B0125, US114B0128, US114B0129, US114B0161, US114B0185, US114B0186, US114B0201, US114B0204, US114B0225, US114B0235, US114B0236, US114B0266, US114B0267, US114B0307, US114B0335, US114B0336, US114B0337, US114B0355, US114B0358, US114B0359, US114B0360, US114B0398, US114B0399, US114B0400, US114B0401, US114B0471, US114B0473, US114B0474, US114B0478, US114B0493, US114B0494, US114B0495, US114B0508, US114B0510, US114B0511, US114B0527, US114B0528, US114B0529, US114B0530, US114B0572, US114B0579, US114B0580, US114B0581, US114B0582, US114B0596, US114B0599, US114B0600, US114B0601, US114B0602, US114B0603, US114B0604, US114B0608, US114B0615, US114B0620, US114B0621, US114B0622, US114B0650, US114B0651, US114B0657, US114B0658, US114B0668, US114B0694, US114B0700, US114B0745, US114B0747, US214B0003, US214B0004, US214B0038, US214B0039, US214B0080, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0817-2015%22
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