Oec Olympus Mobile Fluoroscopy System with Integrated Navigation

• • Terminated Z-0989-2007 FDA Unclassified (pre-2012) ·initiated 6 Jul 2007 ·on shared 510(k) K041931

  The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

• • Terminated Z-0848-2007 FDA Unclassified (pre-2012) ·initiated 12 Jun 2007 ·on shared 510(k) K041931

  X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

• • Terminated Z-0042-2007 FDA Unclassified (pre-2012) ·initiated 30 Sep 2006 ·on shared 510(k) K041931

  X-ray system may lose or mix images and/or lose patient data.

• • Terminated Z-0041-2007 FDA Unclassified (pre-2012) ·initiated 13 Sep 2006 ·on shared 510(k) K041931

  Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.

• • Terminated Z-1301-06 FDA Unclassified (pre-2012) ·initiated 16 Aug 2006 ·on shared 510(k) K041931

  X-ray systems could provide output which exceeds the 20 R/minute limit.

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

510(k) Number

K041931 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K041932 Active Cleared 18 Aug 2004

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