Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from o
FDA device recall Z-0819-2020 · posted 2020-01-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
- Action taken
- The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 205
- Distribution
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
- Date initiated
- 2019-12-16
- Date posted
- 2020-01-17
- Date terminated
- 2023-10-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |