GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 261AWUSV35007H7 10026AW 514934BAR14 26329AW2 ACBCTAW7 956632AW42 321799AW1 617355AWPC1 617355AW3 361595SKW1 617754MR5AW 3454AWW 3526 941747AWW 212639XL5 239436AW2 773792AW1 803366AW1 813642AW42 973972AWW3 973972AWW5 210292AW41C 082445030001AW 082445010004AW 082421010160AW 082421120176AW 082406200003AW 082421150050AW 082416130012AW 082445150008AW 082421100265AW 082421050047AW 083049822101584 083055602101433 083055065231713 083049842101695 PT0004 PT0023 0847490042 0853550153 0853550221 AH4511AW01 030070OT02 EG1277AW01 M4017059 PC0125AW02 PC0815AW03 PC0362AW04 IE1005AW02 A5248812 A5158021 A5226504 KE1000AW01 RU2441AW02 SA1054AW01 NP083626 MP825712 FPG72503 0853550150 TN1003AW02 06056DCS01 70001ADW06 00327ADW01 58831121222 L0235B396 321mraw 420686AW01 B4192933 CC0618AW04 M27534
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare, LLC
- Reason for Recall:
- GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).
Product Codes/Lot Numbers:
261AWUSV35007H7 10026AW 514934BAR14 26329AW2 ACBCTAW7 956632AW42 321799AW1 617355AWPC1 617355AW3 361595SKW1 617754MR5AW 3454AWW 3526 941747AWW 212639XL5 239436AW2 773792AW1 803366AW1 813642AW42 973972AWW3 973972AWW5 210292AW41C 082445030001AW 082445010004AW 082421010160AW 082421120176AW 082406200003AW 082421150050AW 082416130012AW 082445150008AW 082421100265AW 082421050047AW 083049822101584 083055602101433 083055065231713 083049842101695 PT0004 PT0023 0847490042 0853550153 0853550221 AH4511AW01 030070OT02 EG1277AW01 M4017059 PC0125AW02 PC0815AW03 PC0362AW04 IE1005AW02 A5248812 A5158021 A5226504 KE1000AW01 RU2441AW02 SA1054AW01 NP083626 MP825712 FPG72503 0853550150 TN1003AW02 06056DCS01 70001ADW06 00327ADW01 58831121222 L0235B396 321mraw 420686AW01 B4192933 CC0618AW04 M27534
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1960-2012
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