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.
Recall
- Recall Number
- Z-0479-2011
- Event Number
- 52100
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- KPR
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 21, 2009
- Posted
- November 26, 2010
- Terminated
- December 30, 2010
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
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.
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.
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.
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 consignees.
314 units