Z-0306-04

Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630

Name: Z-0306-04 Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630
Creator: General Electric Med Systems
Published: 2003-12-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2003-12-08 / Terminated

FDA source

General Electric Med Systems began a recall of Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630 on 2003-12-08. The reason FDA records is "Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0306-04
Status: Terminated
Initiated: 2003-12-08
Posted: 2004-01-08
Terminated: 2005-11-15
Recalling firm: GE Healthcare
Product: Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
Product code: IYB Tube Mount, X-Ray, Diagnostic
Reason for recall: Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
FDA 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 in commerce: 400
Distribution: Distributed nationwide throughout the US and worldwide.
Product codes and lots: 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.

Product code IYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)