Recall Z-2179-2017 ยท IXR Table, Radiographic, Tilting
GE Healthcare, LLC
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
| Date | May 22, 2017 (initiated Feb 6, 2017) |
| Status | Terminated |
| Reason | Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator. |
| Root cause | Device Design |
| Action | Consignees were sent on 2/6/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10908 dated February 3rd, 2017. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator & Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact consignee to arrange for the correction.. For questions contact GE Healthcare Service at 1-80 |
| Quantity | 2,380 (2,215 US; 165 OUS) |
| Distribution | US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM GE Medical Systems, Jun 8, 2001 |
| K081091 | PRECISION 500D R&F X-RAY SYSTEM GE Healthcare, Jun 11, 2008 |
| K760466 | TABLE, X-RAY, RFX CLASSICAL General Electric Co., Aug 26, 1976 |
| K801320 | SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 General Electric Co., Jul 21, 1980 |
| K862120 | SCX SYSTEM General Electric Co., Jun 16, 1986 |
| K973039 | LEGACY/LEGACY-D TABLE GE Medical Systems, Oct 16, 1997 |