Recall Z-0479-2011 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
| Date | Nov 26, 2010 (initiated Jan 21, 2009) |
| Status | Terminated |
| Reason | Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment. |
| Root cause | Software design |
| Action | Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. Consignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FC0 70600030" with any communication. |
| Quantity | 314 units |
| Distribution | Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. Devices are not distributed to any foreign consig |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |