Recall Z-0012-2014 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a u
| Date | Oct 17, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p |
| Root cause | Employee error |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found. 1. If you observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. 2. If plastic grip is secure, but you observe erratic performance, (power assi |
| Quantity | 810 (783 US, 27 OUS) |
| Distribution | Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM. |
| 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 |
| K973039 | LEGACY/LEGACY-D TABLE GE Medical Systems, Oct 16, 1997 |