Z-1971-2011

Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed...

Name: Z-1971-2011 Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed...
Creator: GE Healthcare, LLC
Published: 2010-06-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-06-10 / Terminated

FDA source

GE Healthcare, LLC began a recall of Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed to perform radiographic and fluoroscopic x-ray... on 2010-06-10. The reason FDA records is "Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1971-2011
Status: Terminated
Initiated: 2010-06-10
Posted: 2011-05-06
Terminated: 2014-09-15
Recalling firm: GE Healthcare
Product: Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outside the permitted field without warning to the user. This issue manifests with symptoms wherein the user cannot fully close down the lateral blades.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare sent an Importan Electronic Product Radiation Warning letter to customers. The letter discussed the product defect description and related hazards, affected product details, instructions, and product correction. The firm will send a GE Field Service Representative to visit each affected customer site to inspect and correct all potentially affected units in the field following the instructions in field modification instructions No: 10846. If you have any questions please call 800-437-1171.
Quantity in commerce: 440 US
Distribution: Nationwide Distribution
Product codes and lots: Part number 5234960.

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)