FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
- Recall number
- Z-1202-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
- Status
- Terminated
- Initiated
- 2013-12-05
- Posted
- 2014-03-27
- Terminated
- 2014-11-06
- Reason
- There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
- Root cause
- Device Design
- Action
- Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
- Quantity
- 19
- Distribution
- USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
- Lot, serial or model codes
- model numbers 10848280, 10848281, 10848282, and 10848283.
- 510(k) numbers
- ["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