Artis Q.zen floor recall
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Why was Artis Q.zen floor 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?
105007
- Product
- Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1
- 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)