BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1003,1004,1009,1013,1016,1028,1031,1032,1033,1036,1037,1038,1040,1042,1052,1059,1066,1070,1083,1095,44983,45511,45514,45519,45523,45530,45531,45535,45537,45538,45540,45542,45543,45550,45551,45567,45568,45569,45570,45571,45573,45575,45577,45578,45579,45581,45583,45588,45593,45595,45599,45602,45603,45604,45607,45609,45610,45611,45613,45614,45618,45619,45620,45621,45623,45624,45625,45627,45628,45629,45630,45631,45633,45635,45636,45637,45638,45639,45640,45642,45643,45644,45645,45648,45649,45650,45651,45652,45653,45654,45655,45657,45658,45659,45661,45662,45663,45664,45666,45701,45702,45703
- 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:
- Siemens Medical Solutions USA Inc.
- Reason for Recall:
- Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Product Codes/Lot Numbers:
Serial Numbers: 1003,1004,1009,1013,1016,1028,1031,1032,1033,1036,1037,1038,1040,1042,1052,1059,1066,1070,1083,1095,44983,45511,45514,45519,45523,45530,45531,45535,45537,45538,45540,45542,45543,45550,45551,45567,45568,45569,45570,45571,45573,45575,45577,45578,45579,45581,45583,45588,45593,45595,45599,45602,45603,45604,45607,45609,45610,45611,45613,45614,45618,45619,45620,45621,45623,45624,45625,45627,45628,45629,45630,45631,45633,45635,45636,45637,45638,45639,45640,45642,45643,45644,45645,45648,45649,45650,45651,45652,45653,45654,45655,45657,45658,45659,45661,45662,45663,45664,45666,45701,45702,45703
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2012-2016
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