Z-0142-2024 Class II Ongoing
FDA device recall Z-0142-2024 was initiated by GE Healthcare on September 8, 2023 and is designated Class II. 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 pati… The recall status is ongoing. Affected quantity: 85 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
Centricity Universal Viewer Workflow Manager, Image processing radiological system
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.
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.
Code Information
UDI/DI 00840682145794, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.