CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Centricity Universal Viewer recalled by GE Medical Systems
GE Medical Systems is recalling Centricity Universal Viewer 6.0, distributed nationwide in the US. The recall was initiated on 28 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0722-2023
- FDA event ID
- 91159
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Oct 2022
- FDA classified
- 16 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Imaging Equipment
Timeline
| 28 Oct 2022 | Recall initiated by company | |
| 16 Dec 2022 | Classified by FDA | +49 days |
| 28 Dec 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Where it was distributed
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.
Nationwide CaliforniaColoradoDelawareFloridaIowaIllinoisMassachusettsMichiganMinnesotaMissouriMississippiMontanaNorth DakotaNew JerseyNew YorkOklahomaOregonSouth DakotaTexasWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Medical Systems | GE Medical Systems | Hidden Drug Ingredients | Nationwide |
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|---|---|---|---|---|---|
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |