Z-0821-2007

Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI

Name: Z-0821-2007 Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
Creator: GE Medical Systems LLC
Published: 2006-12-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-12-21 / Terminated

FDA source

GE Medical Systems LLC began a recall of Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI on 2006-12-21. The reason FDA records is "When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0821-2007
Status: Terminated
Initiated: 2006-12-21
Posted: 2007-05-22
Terminated: 2008-02-24
Recalling firm: GE Healthcare
Product: Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
Product code: IZL System, X-Ray, Mobile
Reason for recall: When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
FDA root cause: Other
Action: Visit to each consignee beginning December 21, 2006.
Quantity in commerce: 6 units
Distribution: Product was distributed in the following states: MS, NE, NJ, and, TX
Product codes and lots: 973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A

Product code IZL

K052897Class IIGe Definium Amx 700, Model Amx 700General Electric Medical Systems / cleared 2005-11-08

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)