Z-2101-2018 Class II Terminated
FDA device recall Z-2101-2018 was initiated by GE Healthcare on Jan 25, 2018 and is designated Class II. Reason for recall: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. The recall status is terminated (terminated Nov 2, 2023). Affected quantity: 44.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- Jan 25, 2018
- Termination Date
- Nov 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44
Product Description
Centricity PACS-IW with Universal Viewer Product Usage: 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason for Recall
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay
Code Information
102747-1-Centricity Universal Viewer-00558673, 11580-1-Centricity Universal Viewer-00558646, 12945-1-Centricity Universal Viewer-00558658, 103852-1-Centricity Universal Viewer-00116028, 103246-1-Centricity Universal Viewer-00558668, 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 101725-2-Centricity Universal Viewer-00558642, 10227-1-Centricity Universal Viewer-00558665, 9768-1-Centricity Universal Viewer-00558661, 100019-1-Centricity Universal Viewer-00558666, 4284-1-Centricity Universal Viewer-00558672, 101272-1-Centricity Universal Viewer-00558671, 100862-1-Centricity Universal Viewer-01444483, 10278-1-Centricity Universal Viewer-00558655, 9789-1-Centricity Universal Viewer-00558645, 12914-1-Centricity Universal Viewer-00558660, 1696-1-Centricity Universal Viewer-00558659, 4408-1-Centricity Universal Viewer-00558664, 4410-1-Centricity Universal Viewer-00558656, 4407-1-Centricity Universal Viewer-00558657, 4407-1-Centricity Universal Viewer-00558652, 4405-1-Centricity Universal Viewer-00558662, 4546-1-Centricity Universal Viewer-00558670, 100064-1-Centricity Universal Viewer-00558572, 100092-1-Centricity Universal ,Viewer-00558648, 1345-1-Centricity Universal Viewer-00558654, 4705-1-Centricity Universal Viewer-00558663, 4418-1-Centricity Universal Viewer-00558674, 102062-1-Centricity Universal Viewer-00558650, 12866-1-Centricity Universal Viewer-01448215, 101931-1-Centricity Universal Viewer-00558569, 4601-1-Centricity Universal Viewer-00558710, 102406-2-Centricity Universal Viewer-00558669, 102406-2-Centricity Universal Viewer-00558667 A59927-Centricity Universal Viewer-00040382, X13479-Centricity Universal Viewer-00043936, and 269338-Centricity Universal Viewer-01453050, 94767-Centricity Universal Viewer-01422997.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2101-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026