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Class 2 Device Recall Centricity Universal Viewer 6.0 |
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| Date Initiated by Firm |
October 28, 2022 |
| Date Posted |
December 16, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0722-2023 |
| Recall Event ID |
91159 |
| 510(K)Number |
K150420
|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product |
Centricity Universal Viewer 6.0.
Used to display medical images (Including mammograms) and data from various imaging sources. |
| Code Information |
Installed Product ID: 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 4405-1-Centricity Universal Viewer-00558662, 4405-1-Centricity Universal Viewer-19508102, 405-1-Centricity Universal Viewer-19050922, 4405-1-Centricity Universal Viewer-19050921, 104535-4-Centricity Universal Viewer-02396030, 104535-3-Centricity Universal Viewer-02396026, 104535-3-Centricity Universal Viewer-02396027, 104535-3-Centricity Universal Viewer-02396028, 104535-3-Centricity Universal Viewer-02396029, 104535-4-Centricity Universal Viewer-01806096, 4406-2-Centricity Universal Viewer-00558683, 4446-2-Centricity Universal Viewer-00558643, 4407-1-Centricity Universal Viewer-00558657, 4407-2-Centricity Universal Viewer-02315681, 4406-2-Centricity Universal Viewer-20501355, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 10227-2-Centricity Universal Viewer-02349137, 4048-1-Centricity Universal Viewer-00558695, 4048-1-Centricity Universal Viewer-14767809, 4048-1-Centricity Universal Viewer-14767808, 4048-1-Centricity Universal Viewer-14767807, 4048-1-Centricity Universal Viewer-14767806, 4048-1-Centricity Universal Viewer-02256595, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4353-2-Centricity Universal Viewer-01589220, 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 4687-1-Centricity Universal Viewer-00558334, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104287-2-Centricity Universal Viewer-00555505, 4451-1-Centricity Universal Viewer-00558107, 100366-1-Centricity Universal Viewer-14777071, 100366-1-Centricity Universal Viewer-00558522, 4583-1-Centricity Universal Viewer-01367198, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 4723-1-Centricity Universal Viewer-02303576, 3245-1-Centricity Universal Viewer-01451973, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 4698-1-Centricity Universal Viewer-00558313, 100159-1-Centricity Universal Viewer-00558324, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 101598-1-Centricity Universal Viewer-00667138, 4382-1-Centricity Universal Viewer-02268547, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 13228-1-Centricity Universal Viewer-00558678, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 9094-1-Centricity Universal Viewer-01766830, 9094-1-Centricity Universal Viewer-01977629, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 100864-1-Centricity Universal Viewer-00558400, 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478, 100581-1-Centricity Universal Viewer-01814001, 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 101690-1-Centricity Universal Viewer-00558680, 101690-1-Centricity Universal Viewer-20091140, 4441-1-Centricity Universal Viewer-00558677, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, 9796-1-Centricity Universal Viewer-00558571, 13225-1-Centricity Universal Viewer-02032334, 2403-7-Centricity Universal Viewer-00558347, 2403-7-Centricity Universal Viewer-01973509, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, 4615-1-Centricity Universal Viewer-01452088.4615-1-Centricity Universal Viewer-20080545, 4347-1-Centricity Universal Viewer-00558520, 100773-1-Centricity Universal Viewer-00558484, 100773-1-Centricity Universal Viewer-20101378, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, AP6264-Centricity Universal Viewer-00000180, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-02097256, 313741-Centricity Universal Viewer-15591262, A91901-Centricity Universal Viewer-00044549, M41980-Centricity Universal Viewer-00044515, HC0399-Centricity Universal Viewer-01282972, CC4105-Centricity Universal Viewer-01282278, PC1695-Centricity Universal Viewer-01447701, 786787-Centricity Universal Viewer-01283171, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, HC4105-Centricity Universal Viewer-00001393, 509940-Centricity Universal Viewer-01813036, 33637-Centricity Universal Viewer-15773152.
HC0245-Centricity Universal Viewer-00059319
600791-Centricity Universal Viewer-02099049
485135-Centricity Universal Viewer-01447706
PC0023-Centricity Universal Viewer-01282279
509585-Centricity Universal Viewer-01826272
601860-Centricity Universal Viewer-01373156
TP0575-Centricity Universal Viewer-01825777
GH1077-Centricity Universal Viewer-01724675
81111-Centricity Universal Viewer-01286673
A59927-Centricity Universal Viewer-00040382
A61971-Centricity Universal Viewer-01891850
KW0000-Centricity Universal Viewer-01416913
PL3673-Centricity Universal Viewer-00038810
PL1494-Centricity Universal Viewer-00038799
PL2970-Centricity Universal Viewer-00038797
PL1124-Centricity Universal Viewer-00038795
PL1499-Centricity Universal Viewer-00038800
PL1501-Centricity Universal Viewer-00038802
PL2624-Centricity Universal Viewer-00038804
PL3277-Centricity Universal Viewer-00038831
PL3362-Centricity Universal Viewer-20631670
PL0326-Centricity Universal Viewer-02040892
PL2975-Centricity Universal Viewer-00162605
PL2971-Centricity Universal Viewer-00038808
SA1339-Centricity Universal Viewer-00116444
16218680-Centricity Universal Viewer-02266272
ZA2551-Centricity Universal Viewer-00116834
MPX352-Centricity Universal Viewer-19629107
DP7603-Centricity Universal Viewer-20093544
FP5028-Centricity Universal Viewer-00110911
124774-Centricity Universal Viewer-00000208
482896-Centricity Universal Viewer-00545574
85021-Centricity Universal Viewer-01426096
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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
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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 |
236 units |
| 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 and Original Applicant = GE HEALTHCARE
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