| Date Initiated by Firm |
May 17, 2019 |
| Create Date |
June 26, 2019 |
| Recall Status1 |
Terminated 3 on November 20, 2023 |
| Recall Number |
Z-1886-2019 |
| Recall Event ID |
83036 |
| 510(K)Number |
K150420
|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product |
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001
Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. |
| Code Information |
Product ID numbers: 102123-1-Centricity Universal Viewer-00558570 102123-1-Centricity Universal Viewer-02157634 2049-1-Centricity Universal Viewer-00558112 1011-1-Centricity Universal Viewer-00558109 1011-1-Centricity Universal Viewer-02097166 1011-1-Centricity Universal Viewer-02097165 4413-2-Centricity Universal Viewer-01300927 4413-2-Centricity Universal Viewer-01300929 101171-1-Centricity Universal Viewer-02288391 104535-4-Centricity Universal Viewer-01806096 104535-4-Centricity Universal Viewer-01806096 4406-1-Centricity Universal Viewer-00558683 4406-1-Centricity Universal Viewer-00558683 4446-2-Centricity Universal Viewer-00558643 4415-1-Centricity Universal Viewer-00558359 4415-1-Centricity Universal Viewer-01973510 4491-1-Centricity Universal Viewer-00558690 100256-1-Centricity Universal Viewer-00558700 100256-1-Centricity Universal Viewer-01810788 104287-2-Centricity Universal Viewer-00555505 4318-1-Centricity Universal Viewer-00558703 4048-1-Centricity Universal Viewer-00558695 4460-1-Centricity Universal Viewer-02255583 4460-1-Centricity Universal Viewer-01819618 4460-7-Centricity Universal Viewer-02255586 101120-1-Centricity Universal Viewer-00558702 102143-1-Centricity Universal Viewer-00558685 4271-1-Centricity Universal Viewer-00558351 4698-1-Centricity Universal Viewer-00558313 4698-1-Centricity Universal Viewer-00558313 100029-1-Centricity Universal Viewer-02256808 100029-1-Centricity Universal Viewer-02256809 100717-1-Centricity Universal Viewer-01293807 100614-1-Centricity Universal Viewer-00558693 13162-8-Centricity Universal Viewer-01452133 101044-1-Centricity Universal Viewer-00558694 101044-1-Centricity Universal Viewer-00558694 102580-1-Centricity Universal Viewer-00558689 100837-1-Centricity Universal Viewer-00558435 104136-1-Centricity Universal Viewer-00558686 104271-1-Centricity Universal Viewer-00558707 103228-1-Centricity Universal Viewer-00558111 4451-1-Centricity Universal Viewer-00558107 101726-1-Centricity Universal Viewer-00558688 100366-1-Centricity Universal Viewer-00558522 4583-1-Centricity Universal Viewer-01367198 13061-1-Centricity Universal Viewer-02205213 13356-2-Centricity Universal Viewer-00558681 12902-1-Centricity Universal Viewer-00602638 3245-1-Centricity Universal Viewer-01451973 4585-3-Centricity Universal Viewer-01448365 101039-1-Centricity Universal Viewer-01373579 13345-1-Centricity Universal Viewer-00602707 9852-2-Centricity Universal Viewer-00558644 9852-2-Centricity Universal Viewer-02267839 102335-1-Centricity Universal Viewer-00558675 100693-1-Centricity Universal Viewer-00558684 13240-2-Centricity Universal Viewer-00558103 4391-1-Centricity Universal Viewer-02205222 4391-1-Centricity Universal Viewer-01459013 100159-1-Centricity Universal Viewer-00558324 13295-1-Centricity Universal Viewer-01292684 101598-1-Centricity Universal Viewer-00667138 4382-1-Centricity Universal Viewer-02268547 102768-1-Centricity Universal Viewer-02179353 102768-1-Centricity Universal Viewer-02255613 100636-1-Centricity Universal Viewer-01815255 13228-1-Centricity Universal Viewer-00558678 4637-1-Centricity Universal Viewer-00558372 4637-1-Centricity Universal Viewer-02176556 4433-1-Centricity Universal Viewer-00558704 4433-1-IDI Mammo Workflow-01608284 101274-1-Centricity Universal Viewer-00558679 101156-1-Centricity Universal Viewer-01970717 102325-1-Centricity Universal Viewer-00558647 4371-1-Centricity Universal Viewer-00558358 4669-1-Centricity Universal Viewer-00558691 100104-1-Centricity Universal Viewer-01299102 4440-1-Centricity Universal Viewer-00558353 104491-1-Centricity Universal Viewer-01288014 102437-1-Centricity Universal Viewer-00558698 102437-1-Centricity Universal Viewer-02254825 4449-1-Centricity Universal Viewer-00558276 3545-3-Centricity Universal Viewer-01546163 4289-1-Centricity Universal Viewer-00558459 4306-1-Centricity Universal Viewer-00558573 4306-1-Centricity Universal Viewer-02263351 4362-1-Centricity Universal Viewer-01299095 4362-1-Centricity Universal Viewer-01299095 100581-1-Centricity Universal Viewer-01814001 1057-1-Centricity Universal Viewer-02180910 1057-1-Centricity Universal Viewer-00558402 1027-1-Centricity Universal Viewer-00558706 104336-1-Centricity Universal Viewer-00346858 4273-3-Centricity Universal Viewer-00558104 101690-1-Centricity Universal Viewer-00558680 4325-51-Centricity Universal Viewer-00599129 4314-1-Centricity Universal Viewer-00558466 13125-1-Centricity Universal Viewer-00558110 13125-1-Centricity Universal Viewer-02268546 4351-1-Centricity Universal Viewer-01627896 4369-1-Centricity Universal Viewer-00558705 102359-1-Centricity Universal Viewer-00558696 4441-1-Centricity Universal Viewer-00558677 4483-1-Centricity Universal Viewer-00558457 13296-1-Centricity Universal Viewer-01364047 9796-1-Centricity Universal Viewer-00558571 9752-1-Centricity Universal Viewer-00558454 4578-1-Centricity Universal Viewer-00558340 13225-1-Centricity Universal Viewer-02032334 100769-1-Centricity Universal Viewer-01298556 100769-1-Centricity Universal Viewer-01298556 13372-1-Centricity Universal Viewer-02283311 11042-1-Centricity Universal Viewer-02285888 4424-2-Centricity Universal Viewer-01474435 100468-1-Centricity Universal Viewer-02182469 4693-1-Centricity Universal Viewer-00558687 12966-1-Centricity Universal Viewer-01283020 2440-1-Centricity Universal Viewer-00558701 2440-1-Centricity Universal Viewer-01973508 102278-1-Centricity Universal Viewer-00558682 4615-1-Centricity Universal Viewer-01452088 101310-1-Centricity Universal Viewer-02039946 4375-1-Centricity Universal Viewer-00558392 4347-1-Centricity Universal Viewer-00558520 4308-1-Centricity Universal Viewer-00558676 100773-1-Centricity Universal Viewer-00558484 4487-1-Centricity Universal Viewer-01291589 4487-1-Centricity Universal Viewer-02097167 AH4325-Centricity Universal Viewer-00160202 AP6264-Centricity Universal Viewer-00000180 AP6264-Centricity Universal Viewer-00000180 AP6264-Centricity Universal Viewer-01980256 AP6264-Centricity Universal Viewer-01980257 AH0116-Centricity Universal Viewer-00160203 AH0106-Centricity Universal Viewer-00160204 300013-Centricity Universal Viewer-00156933 190171-Centricity Universal Viewer-00044015 268882-Centricity Universal Viewer-01422969 571064-Centricity Universal Viewer-01293639 282927-Centricity Universal Viewer-01425170 282927-Centricity Universal Viewer-01806769 339734-Centricity Universal Viewer-01970966 E41676-Centricity Universal Viewer-00043587 X3141198-Centricity Universal Viewer-00043959 M15393-Centricity Universal Viewer-00043611 X1413856-Centricity Universal Viewer-00044474 M45006-Centricity Universal Viewer-00043854 M44917-Centricity Universal Viewer-00043845 M46163-Centricity Universal Viewer-00043858 A54852-Centricity Universal Viewer-00043560 M60364-Centricity Universal Viewer-01801169 M41913-Centricity Universal Viewer-00065993 X3041774-Centricity Universal Viewer-00043956 X2015148-Centricity Universal Viewer-00044553 M44599-Centricity Universal Viewer-00043784 A91901-Centricity Universal Viewer-00044549 M41980-Centricity Universal Viewer-00044515 M41974-Centricity Universal Viewer-00043736 M232471-Centricity Universal Viewer-00043629 M44875-Centricity Universal Viewer-00043829 M44997-Centricity Universal Viewer-00397920 M42176-Centricity Universal Viewer-00043763 HC0399-Centricity Universal Viewer-01282972 CC4105-Centricity Universal Viewer-01282278 PC1695-Centricity Universal Viewer-01447701 UC2011-Centricity Universal Viewer-01282271 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 509940-Centricity Universal Viewer-01813036 509940-Centricity Universal Viewer-01813036 HC0529-Centricity Universal Viewer-01364776 233637-Centricity Universal Viewer-01444341 233637-Centricity Universal Viewer-01444341 233637-Centricity Universal Viewer-01444341 HC0245-Centricity Universal Viewer-00059319 530366-Centricity Universal Viewer-00260659 427990-Centricity Universal Viewer-01813160 427990-Centricity Universal Viewer-01813160 485135-Centricity Universal Viewer-01447706 UHAM02-Centricity Universal Viewer-01447361 PC1961-Centricity Universal Viewer-00001720 PC0023-Centricity Universal Viewer-01282279 HC1642-Centricity Universal Viewer-01634899 531344-Centricity Universal Viewer-00000707 434487-Centricity Universal Viewer-01453839 434487-Centricity Universal Viewer-01453839 CC0154-Centricity Universal Viewer-01813738 HC3062-Centricity Universal Viewer-01462397 509585-Centricity Universal Viewer-01826272 509585-Centricity Universal Viewer-01826272 601860-Centricity Universal Viewer-01373156 PX4900-Centricity Universal Viewer-01369835 PX4900-Centricity Universal Viewer-01369835 HC0565-Centricity Universal Viewer-00545595 TP0575-Centricity Universal Viewer-01825777 TP0575-Centricity Universal Viewer-02283343 GH1077-Centricity Universal Viewer-01724675 FDI-NARAYAN-PACS-IW UV Frontend-01821425 SPARSH-BLR-PACS-IW UV Frontend-01821426 BMHRC-PACS-IW UV Frontend-01821423 MalabarCC-PACS-IW UV Frontend-01820560 MEHROTRA-KNP-PACS-IW UV Frontend-01821431 KVM-ALP-PACS-IW UV Frontend-01821439 GOKULAM-SALEM-PACS-IW UV Frontend-01821438 CETHAR-TRY-PACS-IW UV Frontend-01821437 81111-Centricity Universal Viewer-01286673 IL1469-Centricity Universal Viewer-00040970 A59927-Centricity Universal Viewer-00040382 A54120-Centricity Universal Viewer-00040449 A54120-Centricity Universal Viewer-00040449 KW1005-Centricity Universal Viewer-01300924 KW0000-Centricity Universal Viewer-01416913 AMS39-Centricity Universal Viewer-00545606 BON01-Centricity Universal Viewer-00044131 ECT02-Centricity Universal Viewer-00059842 198952-Centricity Universal Viewer-01970973 225717-Centricity Universal Viewer-01970972 PL3673-Centricity Universal Viewer-00038810 PL1494-Centricity Universal Viewer-00038799 PL2970-Centricity Universal 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RU1112-Centricity Universal Viewer-01453917 RU1112-Centricity Universal Viewer-01977813 RU1112-Centricity Universal Viewer-01980259 RU1107-Centricity Universal Viewer-01273207 tobecreated-Centricity Universal Viewer-01462487 RU1106-Centricity Universal Viewer-01445765 SiteID-Centricity Universal Viewer-01476628 RU3453-Centricity Universal Viewer-01273249 600101-Centricity Universal Viewer-01273190 RU8002-Centricity PACS-IW-01273292 RU1745-Centricity Universal Viewer-01445766 RU5388-Centricity Universal Viewer-01719556 RU5388-Centricity Universal Viewer-01719556 RU8356-Centricity Universal Viewer-01445768 SiteID-Centricity Universal Viewer-01509505 RU3998-Centricity Universal Viewer-01553790 RU3998-Centricity Universal Viewer-01980264 SA2402-Centricity Universal Viewer-01893297 SA1339-Centricity Universal Viewer-00116444 SA1339-Centricity Universal Viewer-00116444 SA1339-Centricity Universal Viewer-00116444 SA1339-Centricity Universal Viewer-00116444 SI4014-Centricity Universal Viewer-01889278 ZA2541-Centricity Universal Viewer-01985829 ZA2267-Centricity Universal Viewer-02001877 ZA1058-Centricity Universal Viewer-01724673 ZA2551-Centricity Universal Viewer-00116834 ZA2472-Centricity Universal Viewer-00116565 ZA00113-Centricity Universal Viewer-01474463 FP5028-Centricity Universal Viewer-00110911 802030-Centricity Universal Viewer-00000462 899010-Centricity Universal Viewer-01300907 899010-Centricity Universal Viewer-01300907 228493-Centricity Universal Viewer-00599935 651948-Centricity Universal Viewer-01813739 124774-Centricity Universal Viewer-00000208 482896-Centricity Universal Viewer-00545574 123953-Centricity Universal Viewer-00163388 06051-Centricity Universal Viewer-00115203 06051-Centricity Universal Viewer-02277628 34381-Centricity Universal Viewer-00116124 48010-Centricity Universal Viewer-01444602 AE1478-Centricity Universal Viewer-00163417 AE1476-Centricity Universal Viewer-01509883 85021-Centricity Universal Viewer-01426096 318055-Centricity Universal Viewer-01457316 |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
| For Additional Information Contact |
800-437-1171
|
Manufacturer Reason
for Recall |
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
|
FDA Determined
Cause 2 |
Software design |
| Action |
The firm issued a medical device correction notice on 05/17/2019. The letter stated the safety issue and provided additional instructions on the use of the system until a service engineer installs the correction. A firm representative will contact the consignee to arrange for the installation. |
| Quantity in Commerce |
292 units |
| Distribution |
Worldwide Distribution - US Nationwide Austria, Belgium, Brazil
Canada
Colombia
France
Germany
Ghana
India
Ireland
Israel
Italy
Kuwait
Mexico
Netherlands
Panama
Poland
Qatar
Russia
Saudi Arabia
Slovenia
South Africa
Spain
Switzerland
Turkey
United Arab Emirates
United Kingdom
Uruguay |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
|
