Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226
- 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:
- Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical 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 or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
Product Codes/Lot Numbers:
Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0108-2021
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