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

FDA device recall Z-1971-2011 · posted 2011-05-06 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAA

Quantity affected

440 US

Distribution

Nationwide Distribution

Date initiated

2010-06-10

Date posted

2011-05-06

Date terminated

2014-09-15

Location

Waukesha, WI