Recall Z-1078-2014— GE Healthcare, LLC

Name: FDA recall Z-1078-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-01-20, terminated 2014-11-03. It names one FDA 510(k) clearance: K102615. Product: GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.. Reason: GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-01-20
Terminated: 2014-11-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K102615 — WIRELESS DR IMAGING OPTION-WDR1Ge Medical Systems, LLC·cleared 2010-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.

Reason for recall

GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I

Data sourced from openFDA. This site is unofficial and independent of the FDA.