Terminated

GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: 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, Neurology and other clinical diagnostic imaging applications.

FDA Recall Z-1094-2009 · Posted 2009-04-10

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeKPS

Date Initiated2008-09-08

Date Terminated2012-05-24

Product Quantity153 US, 264 OUS

Reason for Recall

There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.

Firm Action

Consignees were sent from September 2008 - Feb 2009 a GE "Product Safety Notification" letter dated 4/2008. 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. It instructed consignees to continue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service reps should be contacted for further information regarding the notification.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, DC, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK ,OR, PA, PR, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of AUSTRALIA, BELGIUM , BRASIL, CANADA, CHINA, COLUMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GEORGIA, GERMANY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, NEW Zealand, NORWAY, POLAND, PUERTO RICO, RUSSIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022960GE QUASAR NUCLEAR MEDICINE SYSTEMGe Medical Systems F.I. Haifa · 2002-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.