FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- Recall number
- Z-0012-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- Status
- Terminated
- Initiated
- 2021-08-12
- Posted
- 2021-10-02
- Terminated
- 2024-08-22
- Reason
- A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
- Root cause
- Other
- Action
- This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 49
- Distribution
- AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
- Lot, serial or model codes
- Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
- 510(k) numbers
- ["K182419"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28