PlainRecalls
FDA Devices Moderate Class II Terminated

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 mammog

Reported: March 5, 2014 Initiated: January 20, 2014 #Z-1078-2014

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
359 (333 US, 26 OUS).
Distribution
Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 359 (333 US, 26 OUS)..
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1078-2014.

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