FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
- Recall number
- Z-0183-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
- Status
- Terminated
- Initiated
- 2014-09-23
- Posted
- 2014-11-07
- Terminated
- 2017-05-08
- Reason
- A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.
- Root cause
- Device Design
- Action
- Siemens sent an " Important Safety Information " letter dated September 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Siemens will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Our service organization will contact with you to schedule an appointment to perform the corrective action. Please feel free to contact our service organization for an earlier appointment. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 219-6300.
- Quantity
- 164
- Distribution
- Nationwide Distribution including Puerto Rico.
- Lot, serial or model codes
- model number 10280959, with serial numbers 1000-1599
- 510(k) numbers
- ["K073290"]
- 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