Z-1593-2016 Class II Terminated
FDA device recall Z-1593-2016 was initiated by Carestream Health Inc on April 15, 2016 and is designated Class II. Reason for recall: 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)". The recall status is terminated (terminated March 16, 2017). Affected quantity: US: 50 units; Foreign: 2499 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- April 15, 2016
- Termination Date
- March 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 50 units; Foreign: 2499 units
Product Description
Reason for Recall
Distribution Pattern
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.