| Class 2 Device Recall Centricity PACSIW with Universal Viewer | |
Date Initiated by Firm | October 28, 2022 |
Date Posted | December 16, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0721-2023 |
Recall Event ID |
91159 |
510(K)Number | K123174 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Centricity PACS-IW with Universal Viewer version 5.0.
Used to display medical images (Including mammograms) and data from various imaging sources. |
Code Information |
Installed Product ID: YP3150-Centricity Universal Viewer-01639018 |
Recalling Firm/ Manufacturer |
GE Medical Systems, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | GE Healthcare Service 800-437-1171 |
Manufacturer 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. |
FDA Determined Cause 2 | Software Manufacturing/Software Deployment |
Action | GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study.
2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form. |
Quantity in Commerce | 1 unit |
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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LLZ
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