FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Recall number
- Z-0807-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Status
- Terminated
- Initiated
- 2019-12-20
- Posted
- not on file
- Terminated
- 2020-05-01
- Reason
- The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
- Root cause
- Device Design
- Action
- Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
- Quantity
- 6
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
- Lot, serial or model codes
- Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
- 510(k) numbers
- ["K163286"]
- 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