Z-0899-04

Advantx 1 LC2 Model 2105657 Angiographic X-ray System

Name: Z-0899-04 Advantx 1 LC2 Model 2105657 Angiographic X-ray System
Creator: General Electric Med Systems
Published: 2004-03-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-03-24 / Terminated

FDA source

General Electric Med Systems began a recall of Advantx 1 LC2 Model 2105657 Angiographic X-ray System on 2004-03-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0899-04
Status: Terminated
Initiated: 2004-03-24
Posted: 2004-07-20
Terminated: 2006-07-24
Recalling firm: GE Healthcare
Product: Advantx 1 LC2 Model 2105657 Angiographic X-ray System
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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.
FDA 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.
Distribution: The units were distributed nationwide in the United States and worldwide.
Product codes and lots: All serial numbers

Product code IZI

K890348Class IILc, Cardiac Positioner #B5078aGeneral Electric Co. / cleared 1989-02-27

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)