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)
FDA Recall Z-1578-2015 · Posted 2015-05-05
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Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2015-04-10
Date Terminated2016-02-29
Product Quantity751 units total (246 units in the US and 505 units outside the US)
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).
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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