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Terminated

Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ

FDA Recall Z-0763-2016 · Posted None

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-12-18
Date Terminated2016-09-07
Product Quantity2,111 (1078 US; 1033 OUS)

Reason for Recall

GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.

Firm Action

Consignees were sent on 12/18/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12239 dated December 18, 2015. The letter was address to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122457GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONSGE Healthcare · 2013-01-02K042053INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc. · 2004-08-26K022322INNOVA AND INNOVA 2000 SGe Medical Systems, Inc. · 2002-10-08K974367ADVANTX LCN, ADVANTX LCLPGE Medical Systems · 1998-02-13K960575ADVANTX LCV+GE Medical Systems · 1996-05-07K945375ADVANTX LCAGE Medical Systems · 1995-01-30

Official Source

View FDA Recall →

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

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