ModerateClass IITerminated

FDA Devices recall · Reported December 11, 2013

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 11, 2013. Severity: Moderate. Recall number: Z-0454-2014.

Q: Where was the recalled product distributed?

Distribution: US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI..

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 has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to…

Recall #: Z-0454-2014
Affected scope: 53 units
Initiated: April 19, 2012

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

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Ge Healthcare It recalled The GE Centricity Web; Software Version 3.0x, is intended for use under the direct superv… - a moderate-severity action.

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct superv… was recalled by Ge Healthcare It in December 11, 2013. Reason: GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE …. Check the official notice for the remedy. Verify recall #Z-0454-2014 with the FDA Devices before acting.

The recall

Ge Healthcare It issued this moderate-severity FDA Devices recall-GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE ….

Moderate
severity level: 53 units
affected scope: Class II
classification: December 11, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0454-2014 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

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.

Reason for recall

GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an

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-0454-2014
Date reported	December 11, 2013
Date initiated	April 19, 2012
Recalling firm	Ge Healthcare It
Firm location	Barrington, IL
Affected scope	53 units
Distribution	US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

53 units 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-0454-2014) 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 December 11, 2013. Severity: Moderate. Recall number: Z-0454-2014.

Where was the recalled product distributed? ▼

Distribution: US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI..

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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Similar Medical Devices · nearest report date

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 December 11, 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