FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
- Recall number
- Z-0195-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
- Status
- Terminated
- Initiated
- 2018-08-30
- Posted
- not on file
- Terminated
- 2022-08-31
- Reason
- Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
- Root cause
- Component design/selection
- Action
- On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. 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
- 1
- Distribution
- NY
- Lot, serial or model codes
- SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001
- 510(k) numbers
- ["K150420"]
- 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