General Equipment Cover

• • Terminated Z-1730-2009 FDA Unclassified (pre-2012) ·initiated 29 Aug 2008 ·on shared 510(k) K782155

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

• 4 recalls, same reason

  • Terminated Z-1707-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K782155
  • Terminated Z-1706-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K782155
  • Terminated Z-1709-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K782155
  • Terminated Z-1708-2009 FDA Unclassified (pre-2012) ·initiated 15 Aug 2008 ·on shared 510(k) K782155

  GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

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

510(k) Number

K782155 ↗

FDA Product Code

IZL

Device Class

Class II

Regulation

21 CFR Part 892.1720

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cfi Ultrasound Probe Drape

  Class II

  FDA 510(k) K090773 Active Cleared 18 Sep 2009

• Cfi Restraint Belt (Cfi-168) / Cfi Restraint Belt (Cfi-4046)

  Class I

  FDA 510(k) K963453 Active Cleared 15 Nov 1996

• Cable Holder, Suction Tube Holder

  Class II

  FDA 510(k) K971040 Active Cleared 16 Apr 1997

• GE Sterile Disposable Equipment Coil Cover

  Class II

  FDA 510(k) K964141 Active Cleared 30 Jan 1997

• Instrument Holder

  Class II

  FDA 510(k) K970900 Active Cleared 22 May 1997

• Bandbag, Wrap, Sterile

  Class II

  FDA 510(k) K820692 Active Cleared 3 May 1982

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