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Open, Classified

Centricity Universal Viewer Workflow Manager, Image processing radiological system

FDA Recall Z-0142-2024 · Posted 2023-10-23

Recalling FirmGE Healthcare
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-09-08
Product Quantity85 units

Reason for Recall

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

Firm Action

GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.

Root Cause

Software design

Distribution Pattern

Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182419Centricity Universal ViewerGE Healthcare · 2018-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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