Recall Z-1380-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
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), m
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 11,085 units total (4909 units in the US and 6176 units outside the US) |
| Distribution | Worldwide Distribution: US (nationwide) including Washington, D.C., and countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Aug 21, 2013 |