FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Centricity Universal Viewer Zero Footprint Client
- Recall number
- Z-0329-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Centricity Universal Viewer Zero Footprint Client
- Status
- Open, Classified
- Initiated
- 2021-10-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential to display incomplete patient imaging study.
- Root cause
- Software design
- Action
- The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system.
- Quantity
- 638 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
- Lot, serial or model codes
- Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.
- 510(k) numbers
- K131977
- 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