Precision Rxi Analog X-Ray System

• • Terminated Z-2145-2008 FDA Unclassified (pre-2012) ·initiated 1 May 2008 ·via K041605, on the same 510(k)

  The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.

• 3 recalls, same reason

  • Terminated Z-1564-2008 FDA Unclassified (pre-2012) ·initiated 18 Dec 2007 ·via K041605, on the same 510(k)
  • Terminated Z-1565-2008 FDA Unclassified (pre-2012) ·initiated 18 Dec 2007 ·via K041605, on the same 510(k)
  • Terminated Z-1563-2008 FDA Unclassified (pre-2012) ·initiated 18 Dec 2007 ·via K041605, on the same 510(k)

  GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .

• • Terminated Z-1485-06 FDA Unclassified (pre-2012) ·initiated 1 Nov 2006 ·via K041605, on the same 510(k)

  Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K041605 ↗

FDA Product Code

OWB

FDA applicant

General Medical Merate S.P.A

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Telescop Synchro Stitching

  Class I

  CE/MDR

• Lem Plus 150 Ts

  Class I

  CE/MDR

• CS01MS

  Class I

  CE/MDR

• Lem Plus 150 Ml

  Class I

  CE/MDR

• Lem Plus Ic

  Class I

  CE/MDR

• Lem Plus 180 Ml

  Class I

  CE/MDR

See all devices from General Medical Merate S.P.A. →