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Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: ...

FDA Device Recall #Z-1885-2019 — Class II — May 17, 2019

Recall Summary

Recall Number Z-1885-2019
Classification Class II — Moderate risk
Date Initiated May 17, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 50 units

Product Description

Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Reason for Recall

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

Distribution Pattern

Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay

Lot / Code Information

Product ID numbers: 4405-1-Centricity Universal Viewer-00558662 4410-1-Centricity Universal Viewer-00558656 9789-1-Centricity Universal Viewer-00558645 4408-1-Centricity Universal Viewer-00558664 4284-1-Centricity Universal Viewer-00558672 4407-1-Centricity Universal Viewer-00558652 4407-1-Centricity Universal Viewer-00558657 10227-1-Centricity Universal Viewer-00558665 9768-1-Centricity Universal Viewer-00558661 9768-1-Centricity Universal Viewer-01972254 100019-1-Centricity Universal Viewer-00558666 1045-1-Centricity Universal Viewer-00558651 101725-2-Centricity Universal Viewer-00558642 104249-1-Centricity Universal Viewer-00558667 102406-2-Centricity Universal Viewer-00558669 100064-1-Centricity Universal Viewer-00558572 102062-1-Centricity Universal Viewer-00558650 100722-1-Centricity Universal Viewer-02205220 100862-1-Centricity Universal Viewer-01444483 101272-1-Centricity Universal Viewer-00558671 4705-1-Centricity Universal Viewer-00558663 100092-1-Centricity Universal Viewer-00558648 4418-1-Centricity Universal Viewer-00558674 11580-1-Centricity Universal Viewer-00558646 10278-1-Centricity Universal Viewer-00558655 101931-1-Centricity Universal Viewer-00558569 12945-1-Centricity Universal Viewer-00558658 2403-7-Centricity Universal Viewer-00558347 2403-7-Centricity Universal Viewer-01973509 10372-1-Centricity Universal Viewer-00558654 4601-1-Centricity Universal Viewer-00558710 1696-1-Centricity Universal Viewer-00558659 1696-1-Centricity Universal Viewer-01972253 4546-1-Centricity Universal Viewer-00558670 12866-1-Centricity Universal Viewer-01448215 103246-1-Centricity Universal Viewer-00558668 269338-Centricity Universal Viewer-01453050 94767-Centricity Universal Viewer-01422997 255867-Centricity Universal Viewer-01798076 339362-Centricity Universal Viewer-01970967 X13479-Centricity Universal Viewer-00043936 126292-Centricity Universal Viewer-01282277 HC3062-Centricity Universal Viewer-01462397 HC3062-Centricity Universal Viewer-01462397 JP-ANKLESHWAR-PACS-IW UV Frontend-01821488 MANGALAM-MEH-PACS-IW UV Frontend-01821440 329052-Centricity Universal Viewer-01443407 ZA2533-Centricity Universal Viewer-00116577 SiteID-Centricity Universal Viewer-01998839 YP3150-Centricity Universal Viewer-01639018

Other Recalls from GE Healthcare, LLC

Recall # Classification Product Date
Z-1566-2022 Class II (1) GE Centricity Universal Viewer 6.0, Model 2... Jul 15, 2022
Z-1430-2022 Class II SIGNA Premier magnetic resonance scanner, model... Jun 24, 2022
Z-1466-2022 Class II Centricity PACS Software Version 7.0 SP0.0.4.7 Jun 14, 2022
Z-1333-2022 Class II GE Centricity Universal Viewer Zero Footprint. ... Jun 8, 2022
Z-1511-2022 Class II Service manuals for the CT, PET, or NM table as... Jun 2, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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