CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare
GE Healthcare is recalling Centricity Pacs-iw with Universal Viewer, distributed nationwide in the US. The recall was initiated on 25 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2101-2018
- FDA event ID
- 80159
- Recalling firm
- GE Healthcare, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jan 2018
- FDA classified
- 6 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 25 Jan 2018 | Recall initiated by company | |
| 6 Jun 2018 | Classified by FDA | +132 days |
| 13 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlaskaArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisLouisianaMassachusettsMinnesotaMissouriMississippiMontanaNorth CarolinaNebraskaNew Hampshire
Questions about this recall
Why was it recalled?
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Which lots are affected?
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.
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
More recalls from GE Healthcare
All 512| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | IL |
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