Device Recall GE Centricity PACS RA1000 Workstation 의 리콜

Recall

46306

Class 2

Z-1104-2008

2007-12-28

2008-05-01

Terminated

United States

2010-05-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67160

Report missing characters: four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). this may not be evident to the end user, as the symbols only appear when the exam note window is open.

GE Healthcare IITS sent Product Safety Notification letters dated 12/28/07 to all customers who have the GE Centricity PACS RA1000 Workstation software versions 2.1.X, or 3.0.X, informing them of the potential patient safety issue involving the exam notes window, which may be used to provide various patient information including lab results. To mitigate this problem, the users were instructed not to use the following four special characters (greater than sign >, less than sign <, double quotation mark " and apostrophe ') in the exam notes field in order to prevent any adverse patient events. For example, if a lab result was entered as GFR <60, it should be typed as GFR less than 60. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the problem and the recommended actions provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.