Ventri

• • Ongoing Z-2258-2020 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.

• • Terminated Z-2219-2009 FDA Unclassified (pre-2012) ·initiated 3 Nov 2008

  GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.

510(k) Number

K051855 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Qps/Bpgs/Moco Processing Applications for Entegra Workstation

  Class II

  FDA 510(k) K003264 Active Cleared 21 Dec 2000

• Ventri 1.1 Open recall

  Class II

  FDA 510(k) K080124 Active Cleared 31 Jan 2008

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  FDA 510(k) K093982 Active Cleared 8 Jan 2010

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  Class II

  FDA 510(k) K023932 Active Cleared 11 Dec 2002

• GE Quasar Nuclear Medicine System Open recall

  Class II

  FDA 510(k) K022960 Active Cleared 19 Sep 2002

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  Class II

  FDA 510(k) K093514 Active Cleared 10 Dec 2009

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