Recall record at a glance
| Official record | Z-0763-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Medical Systems, LLC |
| Report date | Feb 17, 2016 |
| Recall initiation date | Dec 18, 2015 |
| Quantity | 2,111 (1078 US; 1033 OUS) |
| Location | Waukesha, WI, United States |
Official product description
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
Why the product was recalled
GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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