Recall Z-1121-2009 ยท KPS System, Tomography, Computed, Emission
GE Medical Systems, LLC
GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neuro
| Date | Apr 10, 2009 (initiated Jun 2, 2008) |
| Status | Terminated |
| Reason | The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis. |
| Root cause | Other |
| Action | Consignees were sent a GE "Product Safety Notification" letter dated April 2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US). |
| Quantity | 122 US and 166 OUS |
| Distribution | Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of Australia, Austria, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022960 | GE QUASAR NUCLEAR MEDICINE SYSTEM Ge Medical Systems F.I. Haifa, Sep 19, 2002 |