Artis Q.zen biplane, Model Number 10848355
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239
- 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:
- If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Artis Q.zen biplane, Model Number 10848355
Product Codes/Lot Numbers:
UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0980-2022
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