EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ

FDA device recall Z-1632-2015 · posted 2015-05-19 · Terminated

Recall details

Recalling firm

Philips Ultrasound, Inc.

Reason for recall

When EPIQ 7 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).

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

1692 units total (902 units in the US and 790 units outside the US)

Distribution

Worldwide Distribution

Date initiated

2015-04-14

Date posted

2015-05-19

Date terminated

2016-08-08

Location

Bothell, WA

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