Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 30, 2013
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist tr
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare It recalled Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication Syst… - a moderate-severity action.
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication Syst… was recalled by Ge Healthcare It in October 30, 2013. Reason: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewe…. Check the official notice for the remedy. Verify recall #Z-0034-2014 with the FDA Devices before acting.
The recall
Ge Healthcare It issued this moderate-severity FDA Devices recall-GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewe….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- October 30, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0034-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0034-2014) was formally reported on October 30, 2013, with the manufacturer initiating the action on October 2, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare It is listed as the recalling firm, operating out of Barrington, IL. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side b… Distribution data in the federal record shows the product reached: USA Nationwide Distribution in the state of OK. 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.
Medical Devices recalls over time
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.
Affected scope
1 unit
Related Recalls
6
3 from same agency
Product description
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
Reason for recall
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0034-2014 |
| Date reported | October 30, 2013 |
| Date initiated | October 2, 2012 |
| Recalling firm | Ge Healthcare It |
| Firm location | Barrington, IL |
| Affected scope | 1 unit |
| Distribution | USA Nationwide Distribution in the state of OK |
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.
- Check the recall number (Z-0034-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.. Recalled by Ge Healthcare It. Units affected: 1 unit.
Why was this product recalled? ▼
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2013. Severity: Moderate. Recall number: Z-0034-2014.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution in the state of OK.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0034-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 October 30, 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.