PlainRecordsFDA · Medical device recall
Centricity Universal Viewer Workflow Manager… and 1 more product
- Date
- Nov. 1, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- GE Healthcare
- Reason
- 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.
2 products in this recall
Centricity Universal Viewer Workflow Manager…
- Product
- Centricity Universal Viewer Workflow Manager, Image processing radiological system
- Quantity
- 85 units
- Codes and lots
- 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.
- Recall started
- Sept. 8, 2023
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-0142-2024
Universal Viewer Workflow Manager…
- Product
- Universal Viewer Workflow Manager, Image processing radiological system
- Quantity
- 57 units
- Codes and lots
- UDI/DI 00195278379610, 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.
- Recall started
- Sept. 8, 2023
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-0143-2024
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0142-2024, Z-0143-2024. The agency record governs; check it and the company before acting.