FDA Device

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thy

Hazard

The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.

What You Should Do

Remedy

The firm, Philips, sent an "Urgent-Medical Device Correction" Philips EPIQ Ultrasound System (MDC 79500381/2), letter dated 2016 MAR 23 to consignees on 3/28/16. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of your staff who need to be aware of the contents of this communication. If, at any time, the control panel assembly on your ultrasound system wobbles or feels loose, stop using your system immediately and contact your local Philips representative or Philips Customer Service at 1-800-722-9377. Otherwise, you may continue to use your system. Philips will contact all EPIQ customers to arrange for service to replace the fasteners connecting the control panel assembly to the system with fasteners less likely to loosen with repeated handling. This service will be performed free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377.

Products

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fet
Brand
Philips Ultrasound, Inc.
UPC
All Serial numbers

Units Affected

11,085 units total (4909 units in the US and 6176 units outside the US)