Recall Z-0528-2010 ยท KPR System, X-Ray, Stationary
GE Medical Systems, LLC
GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of human anatomy.The device is not intended for mammographic applications.
| Date | Dec 16, 2009 (initiated Aug 13, 2009) |
| Status | Terminated |
| Reason | Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place. |
| Root cause | Nonconforming Material/Component |
| Action | A GE Healthcare "Urgent Medical Device Correction" letter dated April 9, 2009 was issued to customers. The letter was addressed to Hospital Administrators/Managers of Radiology and Radiologists. The letter described the Product Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Operators should verify that the tabletop is locked before the patient is loaded on or off the table. A Field Modification will be performed on the affected products. A GE Healthcare Field Engineer will schedule a field visit to make this modification. Direct questions or c |
| Quantity | 5,943 of total product |
| Distribution | Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE Healthcare, Aug 9, 2005 |