Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00840682145794; Serial Numbers: 105906-2-Centricity Universal Viewer-02312613; 6100002127; 4049-1-Centricity Universal Viewer-00104520; 4049-1-Centricity Universal Viewer-00104521; 4049-1-Centricity Universal Viewer-00104522; 6100003887; 9619-c23f-0fae-4eb2-95f8-1529-7e0f-cb89; 103835-2-Centricity Universal Viewer-01370706; 103835-2-Centricity Universal Viewer-01370707; 103835-2-Centricity Universal Viewer-14549671; 103835-2-Centricity Universal Viewer-19676013; 103835-2-Centricity Universal Viewer-19676014; 103835-2-Centricity Universal Viewer-19676015; 103835-2-Centricity Universal Viewer-19676016 103835-2-Centricity Universal Viewer-19735426; 1ec2-1d6c-8e6b-4261-a436-2190-812d-b5df; 10388-1-Centricity Universal Viewer-14762267; 10388-1-Centricity Universal Viewer-17744828; 10388-1-Centricity Universal Viewer-17744829; 10388-1-Centricity Universal Viewer-17744830; 10388-1-Centricity Universal Viewer-17744831; 10388-1-Centricity Universal Viewer-19661410; 6100003912; 4642-6-Centricity Universal Viewer-02255109; 4642-6-Centricity Universal Viewer-02255132; 4642-6-Centricity Universal Viewer-02255133; 4642-6-Centricity Universal Viewer-14580266; 4642-6-Centricity Universal Viewer-14580267; 2457-1-Centricity Universal Viewer-00108168; 3791-1-Centricity Universal Viewer-18836815; 3791-9-Centricity Universal Viewer-15291373; 3791-9-Centricity Universal Viewer-19172098; 6100003882; b1aa-a5a8-dacb-4a74-90ca-41af-c9ed-83dd; 6100003897; 3545-3-Centricity Universal Viewer-00096349; 3545-3-Centricity Universal Viewer-00096350; 3545-3-Centricity Universal Viewer-00158590; 3545-3-Centricity Universal Viewer-00158591; 3545-3-Centricity Universal Viewer-00158592; 3545-3-Centricity Universal Viewer-00158593; 3545-3-Centricity Universal Viewer-00158594; 3545-3-Centricity Universal Viewer-01546163; 3545-3-Centricity Universal Viewer-01764841; 3545-3-Centricity Universal Viewer-01800418; 1198-18-Centricity Universal Viewer-00116885; 1198-18-Centricity Universal Viewer-00116886; 1198-18-Centricity Universal Viewer-00116887; 1198-18-Centricity Universal Viewer-00116888; 1198-18-Centricity Universal Viewer-00116889; 1198-18-Centricity Universal Viewer-00116890; 1198-18-Centricity Universal Viewer-00116891; 1198-18-Centricity Universal Viewer-00116892; 1198-18-Centricity Universal Viewer-00116894; 1198-18-Centricity Universal Viewer-00116895; 1198-18-Centricity Universal Viewer-00116896; 1198-18-Centricity Universal Viewer-00116897; 1198-18-Centricity Universal Viewer-00116898; 1198-18-Centricity Universal Viewer-00116908; 1198-18-Centricity Universal Viewer-01370310; 41a1-fc8a-46c3-48c0-a90d-86fc-4d2e-5676; 100866-1-Centricity Universal Viewer-01287648; 100866-1-Centricity Universal Viewer-01287649; 100866-1-Centricity Universal Viewer-19611328; 100866-1-Centricity Universal Viewer-19611337; 100866-1-Centricity Universal Viewer-19611338; 100866-1-Centricity Universal Viewer-20021255; 100866-1-Centricity Universal Viewer-20021256; 100866-10-Centricity Universal Viewer-19611339; 100866-10-Centricity Universal Viewer-19611340; 100866-10-Centricity Universal Viewer-19611341; 100866-4-Centricity Universal Viewer-19660158; 4314-1-Centricity Universal Viewer-14640637; 4314-1-Centricity Universal Viewer-14776705; 4314-1-Centricity Universal Viewer-14776706; 4314-1-Centricity Universal Viewer-14776707; 4314-1-Centricity Universal Viewer-14776708; 4314-1-Centricity Universal Viewer-14776724; 6bc8-ba1a-6f59-4e1c-a6b8-98b2-7262-75dc; 103915-1-Centricity Universal Viewer-19669927; 6901-11-Centricity Universal Viewer-01974089; 6901-11-Centricity Universal Viewer-02354909; 6901-11-Centricity Universal Viewer-02354910; 6901-11-Centricity Universal Viewer-02354911; 6901-11-Centricity Universal Viewer-02354912; 6901-11-Centricity Universal Viewer-02354913; 7275-45-Centricity Universal Viewer-01891908; 7275-45-Centricity Universal Viewer-19665236; 7275-45-Centricity Universal Viewer-19665240; 7275-45-Centricity Universal Viewer-19665241; 7275-45-Centricity Universal Viewer-19665242; 7275-45-Centricity Universal Viewer-19665243; 7275-45-Centricity Universal Viewer-19665244; 6901-12-Centricity Universal Viewer-02354849; 6901-12-Centricity Universal Viewer-02354850; 6901-12-Centricity Universal Viewer-02354851; 6901-12-Centricity Universal Viewer-02354852; 6901-12-Centricity Universal Viewer-02354853; 6901-12-Centricity Universal Viewer-02354872; 6901-12-Centricity Universal Viewer-02354874; 6901-12-Centricity Universal Viewer-02354875; 6901-12-Centricity Universal Viewer-02354876; 6901-12-Centricity Universal Viewer-02354877; 3760-1-Centricity Universal Viewer-19605860; 3760-1-Centricity Universal Viewer-19727283; 3760-1-Centricity Universal Viewer-19727284; 283043-Centricity Universal Viewer-02285955; 283043-Centricity Universal Viewer-02339571; 283043-Centricity Universal Viewer-14766564
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare, LLC
- Reason for Recall:
- When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Product Codes/Lot Numbers:
UDI: 00840682145794; Serial Numbers: 105906-2-Centricity Universal Viewer-02312613; 6100002127; 4049-1-Centricity Universal Viewer-00104520; 4049-1-Centricity Universal Viewer-00104521; 4049-1-Centricity Universal Viewer-00104522; 6100003887; 9619-c23f-0fae-4eb2-95f8-1529-7e0f-cb89; 103835-2-Centricity Universal Viewer-01370706; 103835-2-Centricity Universal Viewer-01370707; 103835-2-Centricity Universal Viewer-14549671; 103835-2-Centricity Universal Viewer-19676013; 103835-2-Centricity Universal Viewer-19676014; 103835-2-Centricity Universal Viewer-19676015; 103835-2-Centricity Universal Viewer-19676016 103835-2-Centricity Universal Viewer-19735426; 1ec2-1d6c-8e6b-4261-a436-2190-812d-b5df; 10388-1-Centricity Universal Viewer-14762267; 10388-1-Centricity Universal Viewer-17744828; 10388-1-Centricity Universal Viewer-17744829; 10388-1-Centricity Universal Viewer-17744830; 10388-1-Centricity Universal Viewer-17744831; 10388-1-Centricity Universal Viewer-19661410; 6100003912; 4642-6-Centricity Universal Viewer-02255109; 4642-6-Centricity Universal Viewer-02255132; 4642-6-Centricity Universal Viewer-02255133; 4642-6-Centricity Universal Viewer-14580266; 4642-6-Centricity Universal Viewer-14580267; 2457-1-Centricity Universal Viewer-00108168; 3791-1-Centricity Universal Viewer-18836815; 3791-9-Centricity Universal Viewer-15291373; 3791-9-Centricity Universal Viewer-19172098; 6100003882; b1aa-a5a8-dacb-4a74-90ca-41af-c9ed-83dd; 6100003897; 3545-3-Centricity Universal Viewer-00096349; 3545-3-Centricity Universal Viewer-00096350; 3545-3-Centricity Universal Viewer-00158590; 3545-3-Centricity Universal Viewer-00158591; 3545-3-Centricity Universal Viewer-00158592; 3545-3-Centricity Universal Viewer-00158593; 3545-3-Centricity Universal Viewer-00158594; 3545-3-Centricity Universal Viewer-01546163; 3545-3-Centricity Universal Viewer-01764841; 3545-3-Centricity Universal Viewer-01800418; 1198-18-Centricity Universal Viewer-00116885; 1198-18-Centricity Universal Viewer-00116886; 1198-18-Centricity Universal Viewer-00116887; 1198-18-Centricity Universal Viewer-00116888; 1198-18-Centricity Universal Viewer-00116889; 1198-18-Centricity Universal Viewer-00116890; 1198-18-Centricity Universal Viewer-00116891; 1198-18-Centricity Universal Viewer-00116892; 1198-18-Centricity Universal Viewer-00116894; 1198-18-Centricity Universal Viewer-00116895; 1198-18-Centricity Universal Viewer-00116896; 1198-18-Centricity Universal Viewer-00116897; 1198-18-Centricity Universal Viewer-00116898; 1198-18-Centricity Universal Viewer-00116908; 1198-18-Centricity Universal Viewer-01370310; 41a1-fc8a-46c3-48c0-a90d-86fc-4d2e-5676; 100866-1-Centricity Universal Viewer-01287648; 100866-1-Centricity Universal Viewer-01287649; 100866-1-Centricity Universal Viewer-19611328; 100866-1-Centricity Universal Viewer-19611337; 100866-1-Centricity Universal Viewer-19611338; 100866-1-Centricity Universal Viewer-20021255; 100866-1-Centricity Universal Viewer-20021256; 100866-10-Centricity Universal Viewer-19611339; 100866-10-Centricity Universal Viewer-19611340; 100866-10-Centricity Universal Viewer-19611341; 100866-4-Centricity Universal Viewer-19660158; 4314-1-Centricity Universal Viewer-14640637; 4314-1-Centricity Universal Viewer-14776705; 4314-1-Centricity Universal Viewer-14776706; 4314-1-Centricity Universal Viewer-14776707; 4314-1-Centricity Universal Viewer-14776708; 4314-1-Centricity Universal Viewer-14776724; 6bc8-ba1a-6f59-4e1c-a6b8-98b2-7262-75dc; 103915-1-Centricity Universal Viewer-19669927; 6901-11-Centricity Universal Viewer-01974089; 6901-11-Centricity Universal Viewer-02354909; 6901-11-Centricity Universal Viewer-02354910; 6901-11-Centricity Universal Viewer-02354911; 6901-11-Centricity Universal Viewer-02354912; 6901-11-Centricity Universal Viewer-02354913; 7275-45-Centricity Universal Viewer-01891908; 7275-45-Centricity Universal Viewer-19665236; 7275-45-Centricity Universal Viewer-19665240; 7275-45-Centricity Universal Viewer-19665241; 7275-45-Centricity Universal Viewer-19665242; 7275-45-Centricity Universal Viewer-19665243; 7275-45-Centricity Universal Viewer-19665244; 6901-12-Centricity Universal Viewer-02354849; 6901-12-Centricity Universal Viewer-02354850; 6901-12-Centricity Universal Viewer-02354851; 6901-12-Centricity Universal Viewer-02354852; 6901-12-Centricity Universal Viewer-02354853; 6901-12-Centricity Universal Viewer-02354872; 6901-12-Centricity Universal Viewer-02354874; 6901-12-Centricity Universal Viewer-02354875; 6901-12-Centricity Universal Viewer-02354876; 6901-12-Centricity Universal Viewer-02354877; 3760-1-Centricity Universal Viewer-19605860; 3760-1-Centricity Universal Viewer-19727283; 3760-1-Centricity Universal Viewer-19727284; 283043-Centricity Universal Viewer-02285955; 283043-Centricity Universal Viewer-02339571; 283043-Centricity Universal Viewer-14766564
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1533-2021
Related Recalls
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Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.