Recall Z-1915-2016 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
| Date | May 9, 2016 |
| Status | Terminated |
| Reason | GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie |
| Root cause | Process control |
| Action | The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter ,GEHC Ref# 25468, dated May 9, 2016 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions; continue to use your Revolution CT product; follow the Patient Positi |
| Quantity | 197 (US = 68; OUS = 129) |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133705 | REVOLUTION CT Ge Medical Systems, LLC, Apr 11, 2014 |