Recall record at a glance
| Official record | Z-0225-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | Nov 11, 2015 |
| Recall initiation date | Sep 28, 2015 |
| Quantity | Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units |
| Location | Barrington, IL, United States |
Official product description
The 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Why the product was recalled
Inaccurate distance measurements with magnified projection X-ray images.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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