Recall Z-0012-2014— GE Healthcare, LLC

Name: FDA recall Z-0012-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-08-30, terminated 2014-05-22. It names 5 FDA 510(k) clearances: K081091, K011624, K973039 and 2 more. Product: 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 universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.. 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.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Terminated: 2014-05-22
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K081091 — PRECISION 500D R&F X-RAY SYSTEMGE Healthcare·cleared 2008-06-11
K011624 — EXPEDIO 500D R&F X-RAY SYSTEMGE Medical Systems·cleared 2001-06-08
K973039 — LEGACY/LEGACY-D TABLEGE Medical Systems·cleared 1997-10-16
K801320 — SFX-90 TABLE/SPOTFILMER W/FLUORICON L200General Electric Co.·cleared 1980-07-21
K760466 — TABLE, X-RAY, RFX CLASSICALGeneral Electric Co.·cleared 1976-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.