GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration
Class I - DangerousWhat Should You Do?
- Check if you have this product: Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001
- 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 software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration
Product Codes/Lot Numbers:
Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001
Distribution:
Distributed in: GA, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1164-2013
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