Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and dat
Summary
The FDA issued a Class II for Centricity PACS-IW with Universal Viewer version 5.0. Used to display medic by GE Medical Systems, LLC. Reason: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studi.
Details
Source
Device Recall
External ID
Z-0721-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Lot/Code Info: Installed Product ID: YP3150-Centricity Universal Viewer-01639018
Quantity Affected: 1 unit
Reason for Recall
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
Distribution
Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-28
Company
Waukesha, WI
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 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
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 (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0721-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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