Recall Z-1989-2014 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
| Date | Jul 2, 2014 (initiated Jun 4, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury. |
| Root cause | Equipment maintenance |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated June 4, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in regard to this recall the consignees in the United States were advised to call 800-437-1171. For other countries contact your local GE Healthcare Service Representative. For questions regarding this recall call 800-437-1171. |
| Quantity | 1053 |
| Distribution | Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012389 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM Ge Medical Systems, Inc., Aug 10, 2001 |