FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
- Recall number
- Z-0722-2023
- Recalling firm
- GE Medical Systems, LLC
- Product
- Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
- Status
- Open, Classified
- Initiated
- 2022-10-28
- Posted
- 2022-12-16
- Terminated
- not on file
- Reason
- There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study. 2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form.
- Quantity
- 236 units
- Distribution
- Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
- Lot, serial or model codes
- Installed Product ID: 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 4405-1-Centricity Universal Viewer-00558662, 4405-1-Centricity Universal Viewer-19508102, 405-1-Centricity Universal Viewer-19050922, 4405-1-Centricity Universal Viewer-19050921, 104535-4-Centricity Universal Viewer-02396030, 104535-3-Centricity Universal Viewer-02396026, 104535-3-Centricity Universal Viewer-02396027, 104535-3-Centricity Universal Viewer-02396028, 104535-3-Centricity Universal Viewer-02396029, 104535-4-Centricity Universal Viewer-01806096, 4406-2-Centricity Universal Viewer-00558683, 4446-2-Centricity Universal Viewer-00558643, 4407-1-Centricity Universal Viewer-00558657, 4407-2-Centricity Universal Viewer-02315681, 4406-2-Centricity Universal Viewer-20501355, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 10227-2-Centricity Universal Viewer-02349137, 4048-1-Centricity Universal Viewer-00558695, 4048-1-Centricity Universal Viewer-14767809, 4048-1-Centricity Universal Viewer-14767808, 4048-1-Centricity Universal Viewer-14767807, 4048-1-Centricity Universal Viewer-14767806, 4048-1-Centricity Universal Viewer-02256595, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4353-2-Centricity Universal Viewer-01589220, 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 4687-1-Centricity Universal Viewer-00558334, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104287-2-Centricity Universal Viewer-00555505, 4451-1-Centricity Universal Viewer-00558107, 100366-1-Centricity Universal Viewer-14777071, 100366-1-Centricity Universal Viewer-00558522, 4583-1-Centricity Universal Viewer-01367198, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 4723-1-Centricity Universal Viewer-02303576, 3245-1-Centricity Universal Viewer-01451973, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 4698-1-Centricity Universal Viewer-00558313, 100159-1-Centricity Universal Viewer-00558324, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 101598-1-Centricity Universal Viewer-00667138, 4382-1-Centricity Universal Viewer-02268547, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 13228-1-Centricity Universal Viewer-00558678, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 9094-1-Centricity Universal Viewer-01766830, 9094-1-Centricity Universal Viewer-01977629, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 100864-1-Centricity Universal Viewer-00558400, 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478, 100581-1-Centricity Universal Viewer-01814001, 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 101690-1-Centricity Universal Viewer-00558680, 101690-1-Centricity Universal Viewer-20091140, 4441-1-Centricity Universal Viewer-00558677, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, 9796-1-Centricity Universal Viewer-00558571, 13225-1-Centricity Universal Viewer-02032334, 2403-7-Centricity Universal Viewer-00558347, 2403-7-Centricity Universal Viewer-01973509, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, 4615-1-Centricity Universal Viewer-01452088.4615-1-Centricity Universal Viewer-20080545, 4347-1-Centricity Universal Viewer-00558520, 100773-1-Centricity Universal Viewer-00558484, 100773-1-Centricity Universal Viewer-20101378, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, AP6264-Centricity Universal Viewer-00000180, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-02097256, 313741-Centricity Universal Viewer-15591262, A91901-Centricity Universal Viewer-00044549, M41980-Centricity Universal Viewer-00044515, HC0399-Centricity Universal Viewer-01282972, CC4105-Centricity Universal Viewer-01282278, PC1695-Centricity Universal Viewer-01447701, 786787-Centricity Universal Viewer-01283171, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, HC4105-Centricity Universal Viewer-00001393, 509940-Centricity Universal Viewer-01813036, 33637-Centricity Universal Viewer-15773152. HC0245-Centricity Universal Viewer-00059319 600791-Centricity Universal Viewer-02099049 485135-Centricity Universal Viewer-01447706 PC0023-Centricity Universal Viewer-01282279 509585-Centricity Universal Viewer-01826272 601860-Centricity Universal Viewer-01373156 TP0575-Centricity Universal Viewer-01825777 GH1077-Centricity Universal Viewer-01724675 81111-Centricity Universal Viewer-01286673 A59927-Centricity Universal Viewer-00040382 A61971-Centricity Universal Viewer-01891850 KW0000-Centricity Universal Viewer-01416913 PL3673-Centricity Universal Viewer-00038810 PL1494-Centricity Universal Viewer-00038799 PL2970-Centricity Universal Viewer-00038797 PL1124-Centricity Universal Viewer-00038795 PL1499-Centricity Universal Viewer-00038800 PL1501-Centricity Universal Viewer-00038802 PL2624-Centricity Universal Viewer-00038804 PL3277-Centricity Universal Viewer-00038831 PL3362-Centricity Universal Viewer-20631670 PL0326-Centricity Universal Viewer-02040892 PL2975-Centricity Universal Viewer-00162605 PL2971-Centricity Universal Viewer-00038808 SA1339-Centricity Universal Viewer-00116444 16218680-Centricity Universal Viewer-02266272 ZA2551-Centricity Universal Viewer-00116834 MPX352-Centricity Universal Viewer-19629107 DP7603-Centricity Universal Viewer-20093544 FP5028-Centricity Universal Viewer-00110911 124774-Centricity Universal Viewer-00000208 482896-Centricity Universal Viewer-00545574 85021-Centricity Universal Viewer-01426096
- 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