Recall Z-1578-2015 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2)
| Date | May 5, 2015 (initiated Apr 10, 2015) |
| Status | Terminated |
| Reason | When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). |
| Root cause | Software design |
| Action | Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 and Ultrasound system letter, dated 2015 APRIL 10, and the Urgent-Medical Device Correction-Philips Model EPIQ7 and Ultrasound system letter, dated 2015 APRIL 10, letters to their consignees. These systems WITH Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500336 for EPIQ5 -FCO 79500337 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377. |
| Quantity | 751 units total (246 units in the US and 505 units outside the US) |
| Distribution | Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Aug 21, 2013 |