Recall Z-1078-2014 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare, LLC
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
| Date | Feb 24, 2014 (initiated Jan 20, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated January 20, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information ( In USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative). |
| Quantity | 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, FRAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102615 | WIRELESS DR IMAGING OPTION-WDR1 Ge Medical Systems, LLC, Nov 18, 2010 |