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U.S. Department of Health and Human Services

Class 2 Device Recall EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option

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  Class 2 Device Recall EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option see related information
Date Initiated by Firm April 14, 2015
Date Posted May 19, 2015
Recall Status1 Terminated 3 on August 08, 2016
Recall Number Z-1631-2015
Recall Event ID 71105
510(K)Number K132304  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the 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)

Diagnostic ultrasound imaging and fluid flow analysis.
Code Information ********************SYSTEM BASE ID IN THE US*****************************  US114C0207, US114C0208, US114C0209, US114C0287, US114C0308, US114C0323, US114C0330, US114C0445, US114C0713, US114C0714, US114C0731, US115C0139, US115C0464, US115C0465, US115C0470, US115C0471, US115C0537, US115C0538, US115C0539, US115C0576, US115C0607, US214C0042, US214C0084, US214C0103, US214C0104, US214C0105, US214C0141, US214C0142, US214C0162, US214C0180, US214C0434, US215C0068, US215C0069, US215C0070, US215C0072, US215C0073, US215C0074, US215C0171, US215C0172, US215C0178, US215C0179, US215C0180, US215C0306, US215C0307, US215C0308, US215C0406, US215C0407, US215C0449, US215C0450, US215C0512, US215C0513, US215C0514, US215C0516, US215C0534, US215C0535, US215C0538, US215C0539, US215C0571, US215C0572, US215C0573, US215C0615, US215C0616, US215C0617, US215C0618, US215C0619, US215C0620, US215C0624, US215C0625, US215C0626, US215C0627, US215C0713, US215C0714, US215C0715, US215C0716, US215C0717, 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   *********************SYSTEM BASE ID IN CANANA****************************  US115C0433, US115C0495, US115C0496, US115C0497, US115C0498, US115C0499, US115C0571, US215C0348, US215C0566, US215C0567, US215C0679, US215C1042, US315C0090, US315C0404, US315C0405, US315C0406, US414C0604, US714C0076, US714C0297, US814C0111, US914C0200, USD14C0156, USN14C0382, USN14C0383, USN14C0384, USO14C0511, USO14C0512, and USO14C0566.     ********************SYSTEM BASE ID IN OTHER COUNTRIES******************  US114B0005, US114B0006, US114C0081, US114C0082, US114C0107, US114C0110, US114C0143, US114C0144, US114C0145, US114C0146, US114C0147, US114C0148, US114C0192, US114C0193, US114C0194, US114C0211, US114C0238, US114C0309, US114C0320, US114C0348, US114C0363, US114C0366, US114C0408, US114C0409, US114C0442, US114C0446, US114C0532, US115C0017, US115C0052, US115C0053, US115C0054, US115C0100, US115C0101, US115C0137, US115C0138, US115C0141, US115C0178, US115C0179, US115C0180, US115C0181, US115C0212, US115C0213, 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Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Customer Service
800-722-9377
Manufacturer Reason
for Recall		 When EPIQ 5 Ultrasound System, WITHOUT 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 display of their values and incorrect calculation of the patients Body Surface Area (BSA).
FDA Determined
Cause 2		 Software design
Action Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 Ultrasound system and the Urgent-Medical Device Correction-Philips Model EPIQ7 Ultrasound system letters, both dated 2015 APR 14, to their US consignees. Philips sent the Urgent-Field Safety Notice-Philips Model EPIQ5 Ultrasound system letter and the Urgent-Field Safety Notice-Philips Model EPIQ7 Ultrasound system letter (both letters dated 2015 APRIL 14) to their foreign consignees. The EPIQ5 or EPIQ7 Ultrasound systems WITHOUT the Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500340 for EPIQ5 -FCO 79500341 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377. Field Service Engineers (FSE) to install software version 1.3.3 per FCO 79500340 instructions for EPIQ5 5 and per FCO 79500341 instructions for EPIQ7.
Quantity in Commerce Total 1108 units (490 units in US and 618 units outside the US)
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = PHILIPS ULTRASOUND, INC.
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