Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and d...
FDA Device Recall #Z-0722-2023 — Class II — October 28, 2022
Recall Summary
| Recall Number | Z-0722-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 28, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 236 units |
Product Description
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
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 Pattern
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.
Lot / 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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|---|---|---|---|
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| Z-1569-2026 | Class II | Centricity Universal Viewer Software Versions 7... | Jan 30, 2026 |
| Z-1570-2026 | Class II | Centricity Universal Viewer Software Versions 6... | Jan 30, 2026 |
| Z-1571-2026 | Class II | Centricity Universal Viewer Software Versions 5... | Jan 30, 2026 |
| Z-0875-2026 | Class II | Senographe Pristina, Pristina Serena, and Prist... | Oct 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.