Lower riskMedical device recall · FDA · Published October 9, 2023
Philips Affiniti 70 Ultrasound System Recall: Delayed Images Risk
Philips recalls Affiniti 70 ultrasound systems with software version 10.0 that may show delayed images instead of real-time. Affected units have specific serial numbers and model numbers. Contact Philips for remedy.
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.
“Philips Affiniti 70 Ultrasound System Recall: Delayed Images Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57125-philips-affiniti-70-ultrasound-system-recall-delayed-images-risk. Based on FDA recall #Z-0284-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2024%22&limit=1).
The FDA announced on Oct. 9, 2023, that Philips Ultrasound, Inc. is recalling the Philips Affiniti 70 Diagnostic Ultrasound System due to a potential delayed image hazard. The agency issued recall number Z-0284-2024 for the voluntary Class II action.
How to tell if you have it
Brand: Philips
Product: Philips Affiniti 70, Diagnostic Ultrasound System
Model #: 795210
UPC: 00884838106611
Software version: 10.0
Serial numbers: US523F1930, US918F1158, US918F1159, US723F1377, US523F1496, US523F1497, US217F0292
Quantity: 7 systems
The hazard
According to the FDA, diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Context
GovInfoNow's records show Philips Ultrasound, Inc. has had 14 other recalls on record since April 29, 2019. Recent brand recalls include the Sept. 5, 2025 Philips Mini Multi TEE Ultrasound Transducer Recall and the July 3, 2025 Philips Ultrasound C10-3v Transducer Probe Recall, both addressing useful life clarifications. Other recent recalls of similar products include the Aug. 21, 2026 Philips Achieva 3.0T MRI Recalled and the Aug. 7, 2026 Philips EPIQ Elite Ultrasound System Recall.
How to tell if you have this one
Check for model number 795210 with serial numbers listed: US523F1930, US918F1158, US918F1159, US723F1377, US523F1496, US523F1497, US217F0292. The system operates with software version 10.0.
Brand
Philips
Product
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Recall number
Product, codes & lots
Quantity
Z-0283-2024
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); Following model numbers and serial numbers operating with software version 10.0: Model 795200/UDI:(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185 US617B1186 US617B1187 US318B2182 USN19B1084 USD13B0543 US419B1858 US419B1860 US419B1949; Model 795201/UDI:(01)00884838047693/Serial Number: USN16B0579; Model # 795202/UDI: (01)00884838047693/ Serial Numbers: US416B1186 US813B0429 US813B0430 US813B0432 USD16B1124 USD16B1126 USD16B1129 US419B1141 US419B1142 US419B1143 US419B1289 USO18B1195; Model 795204/ UDI: (01)00884838047686/ Serial Numbers: US220C0963 US818C1422 US818C1432 US818C1433 US818C1434 US719C0684; model # 795206/ UDI: (01)00884838047686/ Serial Numbers: USD16C1116 USD17C0754 USD18C0039 USO15C0951 US320C0864 Model # 795231/ UDI: (01)00884838114135/ Serial numbers: US723B1124 US120B0345 US120B0348 US120B1131 US723B1125 US723B1121 US723B1122 US723B1123; Model # 795234/UDI: (01)00884838107540/ Serial numbers: USO22B0941 US322B0678 US322B0676 US723B1023 US723B1126 US723B1024 US723B1022 US723B1128 US723B1127 US423B1238 US723B1021 US521B1455 US723B1017 US323B2026 US723B1018 US723B1019 US223B1718 US223B1719 US223B1720 USD22B0063 US323B0675 US723B1020 US523B0298 US523B0299 US523B0300 US523B2699 US523B2700 US523B2701 US523B2702 US523B2703 US523B2704 US523B2705 US523B2873 US523B2872
83 systems
Z-0284-2024
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210; Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
7 systems
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Philips Affiniti 70 system; if it is version 10.0, it is affected.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0284-2024 (October 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0284-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.