FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
- Recall number
- Z-1750-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
- Status
- Terminated
- Initiated
- 2013-01-31
- Posted
- 2013-07-17
- Terminated
- 2014-11-12
- Reason
- During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
- Root cause
- Device Design
- Action
- Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.
- Quantity
- 23
- Distribution
- United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
- Lot, serial or model codes
- Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.
- 510(k) numbers
- ["K090745"]
- PMA numbers
- not on file
- Product code
- IZI
- 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