Artis systems with large display from Siemens Medical recall
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Why was Artis systems with large display from Siemens Medical recalled?
Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
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?
Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.
- Product
- Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 17
- Distribution
- US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)