Artis zeego recall
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Why was Artis zeego recalled?
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
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?
160851 160869 160943 160817 160852 160834 160972 160463 160944 160406 160913 160877 160488 160800 160884 160823 160916 160814 160872 160905 160915 160447 160481 160501 160874 160862 160860 160878 160957 160412 160856 160387 160432 160903 160917 160889 160813 160461 160912 160919 160838 160507 160487 160825 160850 160430 160801 160323 160498 160509 161004 160896 160894 160830 160519 160469
- Product
- Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 56
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
- Recall date
- July 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)