FDA Medical Device Recalls (openFDA)
General Electric Med Systems: Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System
- Recall number
- Z-0896-04
- Recalling firm
- General Electric Med Systems
- Product
- Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System
- Status
- Terminated
- Initiated
- 2004-03-24
- Posted
- 2004-07-20
- Terminated
- 2006-07-24
- Reason
- Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
- Root cause
- Other
- Action
- Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.
- Quantity
- not on file
- Distribution
- The units were distributed nationwide in the United States and worldwide.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K890348"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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