CLASS II Device recall · Reported 3 Jul 2019 · 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 17 May 2019 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-1885-2019
- FDA event ID
- 83036
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2019
- FDA classified
- 26 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 17 May 2019 | Recall initiated by company | |
| 26 Jun 2019 | Classified by FDA | +40 days |
| 3 Jul 2019 | 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
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Product as listed by the FDA
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Where it was distributed
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
Questions about this recall
Why was it recalled?
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Which lots are affected?
Product ID numbers: 4405-1-Centricity Universal Viewer-00558662 4410-1-Centricity Universal Viewer-00558656 9789-1-Centricity Universal Viewer-00558645 4408-1-Centricity Universal Viewer-00558664 4284-1-Centricity Universal Viewer-00558672 4407-1-Centricity Universal Viewer-00558652 4407-1-Centricity Universal Viewer-00558657 10227-1-Centricity Universal Viewer-00558665 9768-1-Centricity Universal Viewer-00558661 9768-1-Centricity Universal Viewer-01972254 100019-1-Centricity Universal Viewer-00558666 1045-1-Centricity Universal Viewer-00558651 101725-2-Centricity Universal Viewer-00558642 104249-1-Centricity Universal Viewer-00558667 102406-2-Centricity Universal Viewer-00558669 100064-1-Centricity Universal Viewer-00558572 102062-1-Centricity Universal Viewer-00558650 100722-1-Centricity Universal Viewer-02205220 100862-1-Centricity Universal Viewer-01444483 101272-1-Centricity Universal Viewer-00558671 4705-1-Centricity Universal Viewer-00558663 100092-1-Centricity Universal Viewer-00558648 4418-1-Centricity Universal Viewer-00558674 11580-1-Centricity Universal Viewer-00558646 10278-1-Centricity Universal Viewer-00558655 101931-1-Centricity Universal Viewer-00558569 12945-1-Centricity Universal Viewer-00558658 2403-7-Centricity Universal Viewer-00558347 2403-7-Centricity Universal Viewer-01973509 10372-1-Centricity Universal Viewer-00558654 4601-1-Centricity Universal Viewer-00558710 1696-1-Centricity Universal Viewer-00558659 1696-1-Centricity Universal Viewer-01972253 4546-1-Centricity Universal Viewer-00558670 12866-1-Centricity Universal Viewer-01448215 103246-1-Centricity Universal Viewer-00558668 269338-Centricity Universal Viewer-01453050 94767-Centricity Universal Viewer-01422997 255867-Centricity Universal Viewer-01798076 339362-Centricity Universal Viewer-01970967 X13479-Centricity Universal Viewer-00043936 126292-Centricity Universal Viewer-01282277 HC3062-Centricity Universal Viewer-01462397 HC3062-Centricity Universal Viewer-01462397 JP-ANKLESHWAR-PACS-IW UV Frontend-01821488 MANGALAM-MEH-PACS-IW UV Frontend-01821440 329052-Centricity Universal Viewer-01443407 ZA2533-Centricity Universal Viewer-00116577 SiteID-Centricity Universal Viewer-01998839 YP3150-Centricity Universal Viewer-01639018
Where was it sold?
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
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 83036| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Universal Viewer with Pacs-iw foundation recalled | 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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| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |