FDA Device recall Z-1578-2015
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205 by Philips Ultrasound, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1578-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-10 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
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)
Reason
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).
Identifiers
| code_info | *********************SYSTEM CODES IN THE US*********************************** US114C0108, US114C0206, US114C0210, U…*********************SYSTEM CODES IN THE US*********************************** US114C0108, US114C0206, US114C0210, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0286, US114C0321, US114C0322, US114C0331, US114C0332, US114C0333, US114C0334, US114C0444, US114C0534, US114C0605, US114C0674, US115C0140, US115C0382, US115C0468, US214C0106, US214C0143, US214C0144, US214C0192, US214C0534, US214C0535, US214C0536, US215C0071, US215C0394, US215C0536, US215C0774, US215C0839, US215C0843, US215C0844, US215C1010, US215C1049, US215C1050, US314C0055, US314C0073, US314C0235, US314C0296, US314C0297, US314C0322, US314C0444, US314C0446, US314C0557, US314C0613, US314C0746, US314C0835, US315C0055, US414C0014, US414C0035, US414C0069, US414C0158, US414C0376, US414C0377, US414C0616, US514C0044, US514C0045, US514C0046, US514C0084, US514C0085, US514C0149, US514C0175, US514C0338, US514C0373, US514C0374, US514C0375, US514C0473, US514C0474, US514C0639, US514C0657, US514C0668, US514C |
|---|
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-1578-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.