Ventri 1.1

• • Ongoing Z-2259-2020 FDA Class II ·initiated 30 Nov 2018

  GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

• • Terminated Z-1168-2013 FDA Class II ·initiated 9 Jan 2013

  GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.

510(k) Number

K080124 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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