FDA Device recall Z-2483-2021
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7…
- FDA Device
- Class II
- completed
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7… by Philips Ultrasound, citing due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2483-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-08-06 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Reason
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Identifiers
| code_info | EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)0088483804768…EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391; US118C1388/ (01)00884838047686(21)US118C1388; US118C1389/ (01)00884838047686(21)US118C1389; US119C0516/ (01)00884838047686(21)US119C0516; US119C0517/ (01)00884838047686(21)US119C0517; US119C0644/ (01)00884838047686(21)US119C0644; US121C0839/ (01)00884838047686(21)US121C0839; US219C0823/ (01)00884838047686(21)US219C0823; US219C0949/ (01)00884838047686(21)US219C0949; US319C0210/ (01)00884838047686(21)US319C0210; US518C1519/ (01)00884838047686(21)US518C1519; US518C1528/ (01)00884838047686(21)US518C1528; US719C0285/ (01)00884838047686(21)US719C0285; US719C0603/ (01)00884838047686(21)US719C0603; US918C0543/ (01)00884838047686(21)US918C0543; US918C1811/ (01)00884838047686(21)US918C1811; USD18C1243/ (01)00884838047686(21)USD18C1243; EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A; US114C0240/ N/A; US114C0241/ N/A; US114C0271/ N/A; US114 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2483-2021%22
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