Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G — Class II medical device recall Z-0283-2024
Completed recall by Philips Ultrasound, Inc., reported 2023-11-15, distributed in AZ, CA, CT, FL, GA, ID, IL, KY…. Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a d
| Recall number | Z-0283-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2023-10-09 |
| Classified | 2023-11-08 |
| Reported by FDA | 2023-11-15 |
| Distributed | AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA |
| Countries outside the US | CA |
| Quantity | 83 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838047686, 00884838047693, 00884838107540, 00884838114135 |
| Serial numbers | US115B0264, US120B0345, US120B0348, US120B1131, US220C0963, US223B1718, US223B1719, US223B1720, US318B2182, US320C0864, US322B0676, US322B0678, US323B0675, US323B2026, US416B1186, US419B1141, US419B1142, US419B1143, US419B1289, US419B1858, US419B1860, US419B1949, US423B1238, US516B0839, US516B0840 and 58 more |
| Model numbers | 795200, 795201, 795202, 795204, 795206, 795231, 795234 |
Product
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Reason for recall
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0283-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.