Precision Rxi Analog and Digital X-Ray Systems

• 2 recalls, same reason

  • Terminated Z-2121-2015 FDA Class II ·initiated 12 Jun 2015
  • Terminated Z-2122-2015 FDA Class II ·initiated 12 Jun 2015

  A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

• • Terminated Z-0911-2014 FDA Class II ·initiated 12 Dec 2013

  GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will

510(k) Number

K082243 ↗

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. →