FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
- Recall number
- Z-0481-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
- Status
- Terminated
- Initiated
- 2015-10-30
- Posted
- 2015-12-24
- Terminated
- 2017-03-28
- Reason
- 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.
- Root cause
- Software design
- Action
- Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.
- Quantity
- 17
- Distribution
- US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K073290","K123529"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28