Class 1 Device Recall Optima NM/CT 640

• Date Initiated by Firm: June 13, 2013
• Date Posted: July 24, 2013
• Recall Status: Terminated on June 19, 2014
• Recall Number: Z-1793-2013
• Recall Event ID: 65579
• 510(K)Number: K121019
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
• Code Information: System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: technical services; 262-513-4122
• Manufacturer Reason for Recall: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
• FDA Determined Cause: Device Design
• Action: GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
• Quantity in Commerce: 25
• Distribution: Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS