Terminated

GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. Product 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, Neurology and other clinical diagnostic imaging applications.

FDA Recall Z-1003-2009 · Posted 2009-04-21

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeKPS

Date Initiated2008-06-02

Date Terminated2012-05-24

Product Quantity122 US, 166 OUS

Reason for Recall

GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent po

Firm Action

Consignees were sent from June 2008 to February 2009 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. A GE Healthcare service representative will contact each consignee to schedule the installation of the Pressure Sensitive Device (PSD). Please contact your local sales or service representative for further information regarding this recall. Further information can be found by calling 1-800-437-1171 in the US or Canada or 1-262-896-2890 if outside the US.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution US (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, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the 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.