Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Class I - DangerousWhat Should You Do?
- Check if you have this product: Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A
- 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:
- Shimadzu Medical Systems
- Reason for Recall:
- Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Product Codes/Lot Numbers:
Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A
Distribution:
Distributed in: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0655-2022
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