FDA Device recall Z-0947-2021
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi -…
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi -… by Philips Ultrasound, citing control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0947-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-24 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
Reason
Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
Identifiers
| code_info | Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & E…Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256 (01)00884838088658(21)US220B1203 (01)00884838088658(21)US919B0305 (01)00884838088658(21)USN19B1106 (01)00884838088658(21)US220B1587 (01)00884838088658(21)US919B1343 (01)00884838088658(21)USO19B0137 (01)00884838088658(21)USO19B2575 (01)00884838088658(21)US120B0933 (01)00884838088658(21)US619B1530 (01)00884838088658(21)US420B2445 (01)00884838088658(21)US420B2446 (01)00884838088658(21)US520B1252 (01)00884838088658(21)US520B1253 (01)00884838088658(21)US520B1254 (01)00884838088658(21)US620B2080 (01)00884838088658(21)US620B2081 (01)00884838088658(21)US620B2082 (01)00884838088658(21)US619B1796 (01)00884838088658(21)US520B0405 (01)00884838088658(21)US520B0407 (01)00884838088658(21)US520B0408 (01)00884838088658(21)US520B0404 (01)008 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0947-2021%22
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