Severity
Moderate
FDA Devices recall · Reported December 28, 2022
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 ass…
Ge Medical Systems, LLC recalled Centricity Universal Viewer 6.0. Used to display medical images (Including mammogram… - a moderate-severity action.
Centricity Universal Viewer 6.0. Used to display medical images (Including mammogram… was recalled by Ge Medical Systems, LLC in December 28, 2022. Reason: There is the potential that after installation of the IAS tool, some studies can remain hidden without user n…. Check the official notice for the remedy. Verify recall #Z-0722-2023 with the FDA Devices before acting.
The recall
Ge Medical Systems, LLC issued this moderate-severity FDA Devices recall-There is the potential that after installation of the IAS tool, some studies can remain hidden without user n….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0722-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0722-2023) was formally reported on December 28, 2022, with the manufacturer initiating the action on October 28, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Medical Systems, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 236 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
236 units
Related Recalls
6
3 from same agency
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0722-2023 |
| Date reported | December 28, 2022 |
| Date initiated | October 28, 2022 |
| Recalling firm | Ge Medical Systems, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 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, Sout… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.