CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
The Centricity Universal Viewer recalled by GE Healthcare
GE Healthcare is recalling The Centricity Universal Viewer, distributed nationwide in the US. The recall was initiated on 28 Sep 2015 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-0226-2016
- FDA event ID
- 72472
- Recalling firm
- GE Healthcare, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2015
- FDA classified
- 5 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 28 Sep 2015 | Recall initiated by company | |
| 5 Nov 2015 | Classified by FDA | +38 days |
| 11 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inaccurate distance measurements with magnified projection X-ray images.
Product as listed by the FDA
The Centricity Universal Viewer Version 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. 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) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
Nationwide ArizonaCaliforniaColoradoDelawareFloridaGeorgiaIowaIllinoisIndianaLouisianaMassachusettsMichiganMinnesotaMissouriNew JerseyNew YorkOregonPennsylvaniaSouth CarolinaSouth Dakota
Questions about this recall
Is The Centricity Universal Viewer recalled?
Yes. GE Healthcare recalled The Centricity Universal Viewer on 28 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0226-2016.
Why was it recalled?
Inaccurate distance measurements with magnified projection X-ray images.
Which lots are affected?
2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT
Where was it sold?
Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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