Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341
- 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:
- The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Product Codes/Lot Numbers:
model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341
Distribution:
Distributed in: MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, OH, PA, CO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0854-2015
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