Z-0220-05

Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D...

Name: Z-0220-05 Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D...
Creator: General Electric Med Systems LLC
Published: 2004-12-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-12-30 / Terminated

FDA source

General Electric Med Systems LLC began a recall of Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating... on 2004-12-30. The reason FDA records is "Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0220-05
Status: Terminated
Initiated: 2004-12-30
Posted: 2006-02-14
Terminated: 2006-02-21
Recalling firm: GE Healthcare
Product: Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
FDA root cause: Other
Action: An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
Quantity in commerce: 921
Distribution: globally
Product codes and lots: all serial numbers

Product code JAA

K011624Class IIExpedio 500D r&f X-Ray SystemGE Medical Systems / cleared 2001-06-08

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)