FDA Device recall Z-1380-2016
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultras…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultras… by Philips Ultrasound, citing the fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the en….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1380-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-28 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
Reason
The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.
Identifiers
| code_info | All Serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1380-2016%22
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