Recall archive / FDA device enforcement
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging ... — FDA record Z-0722-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 236 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0722-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Oct 28, 2022
- Center classification date
- Dec 16, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.