Biograph mCT X-4R recall
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and…
Why was Biograph mCT X-4R recalled?
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 1008, 11016, 11017, 11022, 11029, 11036, 11054, 11066, 1010, 1004, 11063, 11027, 11055, 11056, 11058, 11057, 11060, 11064, 11070, 21074, 1003, 1005, 1009, 11015, 11023, 11037, 11042, 11045, 11047, 11052, 11059, 11065, 11031, 1002, 11061, 11068, 1006, 11019, 11041, 11048, 11038, 11039, 11014, 11021, 11028, 11030, 11034, 11069, 21071, 11018, 11013, 11040, 11067, 11025, 11049, 11051, 11050, 11046, 11062, 1007, 1011, 11012, 11020, 11024, 11026, 11035, 11043, 11044, 21072, 21073, 1001
- Product
- Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and…
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Quantity
- 71 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)