GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. Product is used to perform gene

FDA device recall Z-1003-2009 · posted 2009-04-21 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

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

Action taken

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

Status

Terminated

Product code

KPS

Quantity affected

122 US, 166 OUS

Distribution

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,

Date initiated

2008-06-02

Date posted

2009-04-21

Date terminated

2012-05-24

Location

Waukesha, WI

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