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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Healthcare: Centricity PACS and Universal Viewer Software Recalled for Patient Data Mix-ups

Agency Publication Date: October 20, 2023
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Summary

GE HealthCare has recalled 495 units of its Centricity PACS-IW and Universal Viewer software because of a critical error where medical images from two different patients can be saved into a single study. This software, used for processing and viewing radiological images like X-rays and MRIs, may display incorrect patient information during a diagnostic review. This recall affects several versions of the software distributed across the United States and multiple international locations. Consumers and medical facilities should contact GE HealthCare for instructions on how to address this software issue.

Risk

If medical images from two different patients are mixed together, a healthcare provider might make a diagnosis or treatment decision based on the wrong person's scans. This could lead to unnecessary medical procedures, incorrect medications, or the failure to treat a patient's actual condition.

What You Should Do

  1. Identify if your facility is using the affected software by checking for Centricity PACS-IW (versions V3.7.x through 3.7.3.9 SP3), Centricity PACS-IW with Universal Viewer (version 5.0 SPx), or Centricity Universal Viewer (versions 6.0 SP0 through 6.0 SP7.1).
  2. Verify your system's 'Installed Product ID' against the extensive list provided in the recall notice to confirm if your specific installation is impacted.
  3. If you identify an affected system, contact GE HealthCare immediately to receive specific guidance and any necessary software patches or updates.
  4. Consult with your healthcare provider or department head to determine if any patient studies need to be re-reviewed for accuracy if they were processed using the recalled software versions.
  5. For additional questions or technical support, contact GE HealthCare at their customer service portal or call the FDA's consumer line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action/guidance from manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centricity PACS-IW Radiological Image Processing System
Model / REF (148):
101792-1-Centricity PACS-IW-00558370
4345-1-Centricity PACS-IW-00558548
12830-1-Centricity PACS-IW-00558312
4378-1-Centricity PACS-IW-00558498
100663-1-Centricity PACS-IW-00558514
100858-1-Centricity PACS-IW-00558426
100702-1-Centricity PACS-IW-00558539
4109-1-Centricity PACS-IW-00558389
101625-1-Centricity PACS-IW-00558531
4593-1-Centricity PACS-IW-00558488
100009-1-Centricity PACS-IW-00558560
100838-1-Centricity PACS-IW-00558532
4300-1-Centricity PACS-IW-00558207
4294-1-Centricity PACS-IW-00558379
13039-1-Centricity PACS-IW-00558385
13102-1-Centricity PACS-IW-00558512
4694-1-Centricity PACS-IW-00558556
101742-1-Centricity PACS-IW-00558470
101883-1-Centricity PACS-IW-00558487
9791-1-Centricity PACS-IW-00558418
11764-1-Centricity PACS-IW-00558388
101689-1-Centricity PACS-IW-00558326
4744-1-Centricity PACS-IW-00558373
4358-1-Centricity PACS-IW-00558564
1402-7-Centricity PACS-IW-18957305
1402-7-Centricity PACS-IW-19265438
1402-7-Centricity PACS-IW-18166109
1402-7-Centricity PACS-IW-18166110
1402-2-Centricity PACS-IW-18984905
1402-2-Centricity PACS-IW-18985934
1402-2-Centricity PACS-IW-19031647
1402-1-Centricity PACS-IW-17192703
1402-1-Centricity PACS-IW-17192704
1402-1-Centricity PACS-IW-00558291
13095-1-Centricity PACS-IW-00558534
4326-4-Centricity PACS-IW-00558105
4352-1-Centricity PACS-IW-00558316
4443-1-Centricity PACS-IW-00558167
4374-1-Centricity PACS-IW-00558422
4301-1-Centricity PACS-IW-00558525
2387-1-Centricity PACS-IW-00558489
4277-1-Centricity PACS-IW-00558474
100802-1-Centricity PACS-IW-00558540
101216-1-Centricity PACS-IW-00558356
101193-1-Centricity PACS-IW-00558551
101240-1-Centricity PACS-IW-00558425
4661-1-Centricity PACS-IW-00558528
3943-1-Centricity PACS-IW-00558501
4361-1-Centricity PACS-IW-00558343
12949-1-Centricity PACS-IW-00558442
Lot Numbers:
V3.7.x through 3.7.3.9 SP3
Product: Centricity PACS-IW with Universal Viewer
Model / REF:
100707-1-Centricity Universal Viewer-00558649
1045-1-Centricity Universal Viewer-00558651
1045-1-Centricity Universal Viewer-19607785
100759-1-Centricity Universal Viewer-02360986
9842-4-Centricity Universal Viewer-19386293
4723-1-Centricity Universal Viewer-02303576
104648-2-Centricity Universal Viewer-02354806
101272-1-Centricity Universal Viewer-00558671
100713-1-Centricity Universal Viewer-00558259
100713-1-Centricity Universal Viewer-01982629
4705-1-Centricity Universal Viewer-02398923
100512-1-Centricity Universal Viewer-00558264
3727-1-Centricity Universal Viewer-00558421
HC3062-Centricity Universal Viewer-01462397
RU9761-UW PACS-IW UP TO 10K-02336112
ZA2533-Centricity Universal Viewer-00116577
YP3150-Centricity Universal Viewer-01639018
Lot Numbers:
Versions 5.0 SPx with PACS-IW foundation
Product: Centricity Universal Viewer
Model / REF (247):
102123-1-Centricity Universal Viewer-00558570
102123-1-Centricity Universal Viewer-02157634
1011-1-Centricity Universal Viewer-00558109
1011-1-Centricity Universal Viewer-02097166
1011-1-Centricity Universal Viewer-02097165
100666-1-Centricity Universal Viewer-14194768
100666-1-Centricity Universal Viewer-20084199
9789-1-Centricity Universal Viewer-00558645
4413-2-Centricity Universal Viewer-02288447
4267-5-Centricity Universal Viewer-19618406
100763-1-Centricity Universal Viewer-00558366
101171-1-Centricity Universal Viewer-02398531
104535-3-Centricity Universal Viewer-02396026
104535-3-Centricity Universal Viewer-02396027
104535-3-Centricity Universal Viewer-02396028
104535-3-Centricity Universal Viewer-02396029
11438-1-Centricity Universal Viewer-00558464
104535-4-Centricity Universal Viewer-02396030
104535-4-Centricity Universal Viewer-01806096
4415-1-Centricity Universal Viewer-00558359
4415-1-Centricity Universal Viewer-01973510
4308-1-Centricity Universal Viewer-00558676
4308-1-Centricity Universal Viewer-21200827
4308-1-Centricity Universal Viewer-21200830
4318-1-Centricity Universal Viewer-00558703
4318-1-Centricity Universal Viewer-20080694
4048-1-Centricity Universal Viewer-00558695
4048-1-Centricity Universal Viewer-14767809
4048-1-Centricity Universal Viewer-14767808
4048-1-Centricity Universal Viewer-14767807
4048-1-Centricity Universal Viewer-14767806
4048-1-Centricity Universal Viewer-02256595
4460-1-Centricity Universal Viewer-02255583
4460-1-Centricity Universal Viewer-01819618
4460-7-Centricity Universal Viewer-02255586
4460-7-Centricity Universal Viewer-02255587
101280-1-Centricity Universal Viewer-19630914
101280-1-Centricity Universal Viewer-19630915
101280-1-Centricity Universal Viewer-19630916
101280-1-Centricity Universal Viewer-20553950
9768-1-Centricity Universal Viewer-00558661
9768-1-Centricity Universal Viewer-01972254
4552-1-Centricity Universal Viewer-01294074
6579-11-Centricity Universal Viewer-02339896
4353-2-Centricity Universal Viewer-01589220
4698-1-Centricity Universal Viewer-00558313
100029-1-Centricity Universal Viewer-02256808
100717-1-Centricity Universal Viewer-01293807
100717-1-Centricity Universal Viewer-01293808
13162-8-Centricity Universal Viewer-01452133
UPC Codes:
840682103800
Lot Numbers:
Software versions 6.0 SP0 through 6.0 SP7.1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93099
Status: Active
Manufacturer: GE Healthcare
Sold By: Authorized GE HealthCare medical device distributors; Direct sales to hospitals and clinics
Manufactured In: United States
Units Affected: 3 products (149 units; 17 units; 329 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.