Z-1304-06

GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an...

Name: Z-1304-06 GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an...
Creator: General Electric Med Systems LLC
Published: 2006-05-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-05-15 / Terminated / root cause: manufacturing process

FDA source

General Electric Med Systems LLC began a recall of GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube... on 2006-05-15. The reason FDA records is "Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1304-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-09-22
Terminated: 2007-05-25
Recalling firm: GE Healthcare
Product: GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting 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: Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
Root cause tag: manufacturing process
FDA root cause: Other
Action: An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.
Quantity in commerce: 1,289
Distribution: Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.
Product codes and lots: All serial numbers affected

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)