FDA Device recall Z-1632-2015
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number…
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number… by Philips Ultrasound, citing 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 incorr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1632-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-14 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Ultrasound |
| Distribution | n/a |
Product
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis
Reason
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).
Identifiers
| code_info | ********************SYSTEM BASE ID IN THE US***************************** US114B0056, US114B0057, US114B0160, US114B…********************SYSTEM BASE ID IN THE US***************************** US114B0056, US114B0057, US114B0160, US114B0187, US114B0188, US114B0189, US114B0224, US114B0282, US114B0283, US114B0303, US114B0318, US114B0355, US114B0393, US114B0394, US114B0400, US114B0401, US114B0403, US114B0435, US114B0468, US114B0495, US114B0527, US114B0528, US114B0529, US114B0537, US114B0538, US114B0540, US114B0541, US114B0542, US114B0544, US114B0545, US114B0547, US114B0548, US114B0552, US114B0569, US114B0570, US114B0583, US114B0612, US114B0702, US114B0705, US114B0706, US114B0707, US114B0709, US114B0710, US114B0711, US114B0712, US115B0010, US115B0011, US115B0013, US115B0014, US115B0043, US115B0044, US115B0045, US115B0046, US115B0047, US115B0048, US115B0049, US115B0090, US115B0125, US115B0166, US115B0167, US115B0264, US115B0267, US115B0269, US115B0270, US115B0377, US115B0378, US115B0480, US115B0481, US115B0482, US115B0483, US115B0519, US115B0520, US115B0586, US115B0592, US115B0593, US115B0594, US115B0595, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1632-2015%22
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