Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Summary
The FDA issued a Class II for Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 by Philips Ultrasound, Inc.. Reason: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time imag.
Details
Source
Device Recall
External ID
Z-0284-2024
Action Date
2023-11-15
Status
Completed
Category
device
Product Description
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Lot/Code Info: Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
Quantity Affected: 7 systems
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.
Distribution
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-09
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Ultrasound, Inc. has 111 FDA actions in our database, including 111 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, Inc. have FDA actions?
Philips Ultrasound, Inc. has 111 FDA actions in our database, including 111 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0284-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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