Recall Z-1966-2015— GE Healthcare

Name: FDA recall Z-1966-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-06-12, terminated 2015-12-21. It names 2 FDA 510(k) clearances: K081091, K973039. Product: GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.. Reason: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Terminated: 2015-12-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K081091 — PRECISION 500D R&F X-RAY SYSTEMGE Healthcare·cleared 2008-06-11
K973039 — LEGACY/LEGACY-D TABLEGE Medical Systems·cleared 1997-10-16

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 and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.

Reason for recall

The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.

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