Recall record at a glance
| Official record | Z-1593-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carestream Health Inc. |
| Report date | May 11, 2016 |
| Recall initiation date | Apr 15, 2016 |
| Quantity | US: 50 units; Foreign: 2499 units |
| Location | Rochester, NY, United States |
Official product description
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
Why the product was recalled
Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Distribution information
NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.
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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