Carestream Image Suite V3: Mini-pacs/f IMG St/classic recall
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…
Why was Carestream Image Suite V3: Mini-pacs/f IMG St/classic 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)".
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Equipment ID Numbers: US units: 8501-2596, 85018860, 8501-0954, 5241-2596, 5241-2546, 5241-2713, 5296-3447, 52414419, 52414455, 5241-2640, 5241-2716, 54838552, 5483-8502, 8501-4665, 52408158, 85014687, 54839128, 5483-9212, 52412539, 52414661, 52962897, 4745-3986, 5241-2337, 85012262, 8501-5898, 8501-2602, 54838630, 52412670, 5296-3450, 5296-3449, 54838554, 52408157, 54838618, 5241-4547, 54842652, 52420675, 8501-2861, 52414685, 52414751, 5484-3086, 54838598, 52412367, 52414417, 54839211, 54838616, 4745-5991, 52412243, 54842667, 52417149, 52412340; -- Equipment ID Numbers for Foreign Units: Please contact CDRH Recall Group for list of affected Equipment ID Numbers.
- Product
- 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…
- Recalling firm
- Carestream Health Inc
- Quantity
- US: 50 units; Foreign: 2499 units
- Distribution
- 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.
- Recall date
- May 11, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)