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.
Recall
- Recall Number
- Z-1593-2016
- Event Number
- 73742
- Firm
- Carestream Health Inc
- FEI Number
- 1315356
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 15, 2016
- Posted
- May 2, 2016
- Terminated
- March 16, 2017
- Address
- 150 Verona St, Rochester, NY, 14608-1733
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.
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)".
Carestream Health sent an URGENT MEDICAL DEVICE CORRECTION letter dated April 6, 2016, and Consignee Notification Acknowledgement form to the US consignees on April 15, 2016, via Certified Mail, Return Receipt Requested. Foreign consignees are being notified based on the individual country regulations. Customers who have this Image Suite configuration but do not use it for CT or MR Imaging do not need to take any action. Customers who use the product for CT or MR Images are asked to make users aware of the problem and take additional steps to check correct orientation of any markers, until the software is updated. Customers with questions or concerns were instructed to contact the Carestream Customer Care Center in the US at 1-800-328-2910. Customers outside the US were instructed to contact their local Service Support number. For questions regarding this recall call 1-800-328-2917.
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.
US: 50 units; Foreign: 2499 units