Severity
Moderate
FDA Devices recall · Reported April 24, 2013
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected ser…
Ge Healthcare, LLC recalled GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system tha… - a moderate-severity action.
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system tha… was recalled by Ge Healthcare, LLC in April 24, 2013. Reason: GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the…. Check the official notice for the remedy. Verify recall #Z-1137-2013 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1137-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1137-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on June 28, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 429.
The documented reason for this recall is: GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countr…. 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
429
Related Recalls
6
3 from same agency
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1137-2013 |
| Date reported | April 24, 2013 |
| Date initiated | June 28, 2012 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 429 |
| Distribution | Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA,… |
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.
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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 April 24, 2013. 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.