Legacy/Legacy-D Table

• • Terminated Z-2179-2017 FDA Class II ·initiated 6 Feb 2017

  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.

• • Terminated Z-1966-2015 FDA Class II ·initiated 12 Jun 2015 ·on shared 510(k) K973039

  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.

• • Terminated Z-0012-2014 FDA Class II ·initiated 30 Aug 2013 ·on shared 510(k) K973039

  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

• • Terminated Z-1611-2008 FDA Unclassified (pre-2012) ·initiated 2 Jan 2008

  GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K973039 ↗

FDA product code

IXR

Device class

Class II

Regulation

21 CFR Part 892.1980

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

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See all devices from GE Medical Systems, Inc. →

• What is the Legacy/Legacy-D Table used for?

  The Legacy/Legacy-D Table is a radiographic table designed to support patient positioning during imaging examinations in clinical radiology settings. It features tilting functionality to facilitate various radiology procedures.

• Is the Legacy/Legacy-D Table a single-use or reusable device?

  The Legacy/Legacy-D Table is supplied as a reusable device for use in clinical radiology settings. It is designed for multiple patient examinations rather than being disposable.

• What regulatory approvals does the Legacy/Legacy-D Table have?

  The Legacy/Legacy-D Table has received FDA 510(k) clearance under K973039 and is classified as a Class II medical device under regulation 892.1980 with product code IXR.

• How is the Legacy/Legacy-D Table supplied?

  The Legacy/Legacy-D Table is supplied as a complete radiographic table system with tilting capabilities. It is designed for integration into clinical radiology environments for patient imaging procedures.