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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 30, 2013. Severity: Moderate. Recall number: Z-0034-2014.

Q: Where was the recalled product distributed?

Distribution: USA Nationwide Distribution in the state of OK.

Q: 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.

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. …

Recall #: Z-0034-2014
Affected scope: 1 unit
Initiated: October 2, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Devices recall record
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.

Scale of Impact

1 unit units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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? ▼

Why was this product recalled? ▼

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.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported October 30, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026