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U.S. Department of Health and Human Services

Class 2 Device Recall GE Senographe Pristina

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  Class 2 Device Recall GE Senographe Pristina see related information
Date Initiated by Firm May 16, 2019
Create Date July 30, 2019
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-2131-2019
Recall Event ID 83096
510(K)Number K162268  
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
Product GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.
Code Information Serial# 716784BU4, 716785BU1, 716786BU9, 716787BU7, 716788BU5, 718583BU8, 718584BU6, 718585BU3, 718586BU1, 718587BU9, 718588BU7, 718589BU5, 718591BU1, 718592BU9, 718593BU7, 718594BU5, 718595BU2, 718596BU0, 718597BU8, 718598BU6, 718599BU4 , 718600BU0, 718601BU8, 718602BU6, 722648BU3, 722649BU1, 722653BU3, 722654BU1, 722655BU8, 722656BU6, 722657BU4, 730124BU5, 730125BU2, 730126BU0, 730292BU0, 730293BU8, 730663BU2, 730664BU0, 730665BU7, 732049BU2, 732050BU0, 732303BU3, 732304BU1, 732305BU8, 732362BU9, 732363BU7, 732448BU6, 732449BU4, 732450BU2, 732727BU3, 732728BU1, 733031BU9, 733903BU9, 733904BU7, 734170BU4, 734206BU6, 734840BU2, 735432BU7, 735779BU1, 736006BU8, 736007BU6, 736008BU4, 736366BU6, 736588BU5, 738021BU5, 738356BU5, 738357BU3 , 738358BU1, 738557BU8, 738573BU5, 738586BU7, 738587BU5, 738712BU9, 738792BU1, 738794BU7, 738795BU4, 738864BU8, 739150BU1 and 739721BU9.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
FDA Determined
Cause 2		 Equipment maintenance
Action On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,
Quantity in Commerce 82
Distribution Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and 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 = MUE and Original Applicant = GE HEALTHCARE
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