Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 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: 1024,1001,1002,1003,1005,1006,1007,1008,1009,1011,1012,1013,1004,1014,1017,1018,1019,1020,1022,1010,1023,11034,1016,1015,1025,11026,11029,11028,11030,11031,11035,11032,11033,11027,11036,11037,11039,11038,11040,11043,11044,11045,11046,11083,11047,11041,11042,11049,11051,11050,11053,11054,11055,11056,11057,11058,11059,11076,11060,11061,11062,11063,11064,11052,11065,11048,11074,11069,11067,11068,11070,11072,11075,11073,11066,11077,11078,11071,11080,11081,11082,11084,21085,21086,21087,21088,21089,21090,21091,31092,21093,31094,31095,31097,31096,31099,91001,31100,1021,31098
- 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 mCT-S(40) 4R, MATERIAL NUMBER 10248671 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: 1024,1001,1002,1003,1005,1006,1007,1008,1009,1011,1012,1013,1004,1014,1017,1018,1019,1020,1022,1010,1023,11034,1016,1015,1025,11026,11029,11028,11030,11031,11035,11032,11033,11027,11036,11037,11039,11038,11040,11043,11044,11045,11046,11083,11047,11041,11042,11049,11051,11050,11053,11054,11055,11056,11057,11058,11059,11076,11060,11061,11062,11063,11064,11052,11065,11048,11074,11069,11067,11068,11070,11072,11075,11073,11066,11077,11078,11071,11080,11081,11082,11084,21085,21086,21087,21088,21089,21090,21091,31092,21093,31094,31095,31097,31096,31099,91001,31100,1021,31098
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2031-2016
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