EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 79
FDA device recall Z-1578-2015 · posted 2015-05-05 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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.
- Date initiated
- 2015-04-10
- Date posted
- 2015-05-05
- Date terminated
- 2016-02-29
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPIQ DIAGNOSTIC ULTRASOUND SYSTEM (K132304) | Philips Ultrasound, Inc. | 2013-08-21 |