Z-0284-2024Class II

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Name: Z-0284-2024 Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Creator: Philips Ultrasound, Inc.
Published: 2023-10-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-09 / Completed / root cause: software

FDA source

Philips Ultrasound, Inc. began a recall of Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 on 2023-10-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0284-2024
Classification: Class II
Status: Completed
Initiated: 2023-10-09
Posted: 2023-11-09
Recalling firm: Philips North America LLC
Product: Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
Action: On October 9, 2023, Philips issued a Urgent Medical Device Correction notification to affected consignees. Philips asked consignees to take the following actions: 1. Identify if your firm has an affected product. 2. In the 2D tab in the system touchscreen, disable the AutoSCAN feature every time a transducer or a Transducer preset is selected to prevent the system from potentially experiencing image lag issue. The AutoSCAN feature is disabled when the button is not highlighted in amber. 3. Please complete and return the attached response form to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 4. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) and ensure the letter is in a place likely to be seen/viewed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax.
Quantity in commerce: 7 systems
Distribution: US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Product codes and lots: Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0284-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2024	Class II	Completed	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0284-2024	Class II	Completed	Voluntary: Firm initiated	2023-11-15	2023-11-08

Product code IYN

K231190Class IIEPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC / cleared 2023-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)