FDA Medical Device Recalls (openFDA)
General Electric Med Systems: Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
- Recall number
- Z-0306-04
- Recalling firm
- General Electric Med Systems
- Product
- Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
- Status
- Terminated
- Initiated
- 2003-12-08
- Posted
- 2004-01-08
- Terminated
- 2005-11-15
- Reason
- Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
- Root cause
- Other
- Action
- Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure.
- Quantity
- 400
- Distribution
- Distributed nationwide throughout the US and worldwide.
- Lot, serial or model codes
- Tube Catalog #''s D3132, D3172, D3182, and D3152 used on Gantry model #''s 2137130, 2137130-5, 2234921-3, 2260619, 2260619-3, 2281177, 2281177-2, 2281177-3, 2281177-4, 2305500, 2339985, 2341799, 2362605, and 5101272.
- 510(k) numbers
- ["K013561","K023988"]
- PMA numbers
- not on file
- Product code
- IYB
- 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