Artis zee floor, Model Number 10094135
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 4056869010045; Serial Numbers: 138481 137729 124071 138390 135944 137623 135111 135112 124267 124253 137165 124335 124338 124400 137391 137714 124081 135120 137282 135358 137618 137226 135757 136513 137103 137118 137461 135102 136042 138124 138132 135927 137510 138260 138012 138058 137193 135986 135935 135953 138055 124303 135841 138497 135200 135201 135279 124061 135879 135229 136113 135990 138035 138214 137479 138156 124083 137532 137540 136077 124102 137314 135862 124116 135235 135117 135920 137295 136168 138087 137582 137592 138221 138112 135366 138084 137075 124115 135843 138057 138118 138061 135779 136224 124395 137130 137188 137131 137146 137662 135137 138071 138102 138486 136579 137388 137470 124007 137011 136280 138311 136286 137347 135109 137766 124384 138128 137638 137731 124383 138017 124394 137595 135144 135145 136362 138259 137245 137620 137335 137607 137617 136318 136234 138402 135151 135421 135760 136500 135217 137369 136031 136032 137421 135124 136084 137569 136026 137425 136479 135285 136338 136196 135245 135420 124051 136384 136387 136488 136256 135767 136408 136508 135182 137650 137668 136242 136383 135788 136517 135406 136043 137311 137320 137360 138163 135129 135416 138004 135222 136393 124268 137639 135302 135260 137736 138194 124273 138325 138358 135143 137645 135114 137093 136350 138193 135253 135772 138201 138250 135190 124378 137591 137438 135881 136614 136567 138104 135714 137656 138119 124302 138147 137239 138005 136089 138367 138397 135180 135184 135922 124119 136314 124703 137296 138015 136190 136197 136254 137458 138070 135813 136970 137229 124388 135791 137112 137218 124080 138230 138266 136561 138268 136505 124006 137244 137231 124118 135793 138346 135132 135148 138180 138480 137513 138458 138513 139012 137217 137224 135723 124111 136126 136217 135847 135281 135373 135196 124344 136557 136558 124286 137511 136391 137297 135909 136143 137403 139023 138357 138381 135384 136582 138340 136345 138188 137567 136459 136518 124314 136290 135233 135353 136594 135203 124056 137667 137579 137551 138051 136137 138190 135397 137518 136278 Additional Serial Numbers as of 10/4/23: 136450 135352 124201 124089 136548 136568 124015 136607 136586 136555
- 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 zee floor, Model Number 10094135
Product Codes/Lot Numbers:
UDI: 4056869010045; Serial Numbers: 138481 137729 124071 138390 135944 137623 135111 135112 124267 124253 137165 124335 124338 124400 137391 137714 124081 135120 137282 135358 137618 137226 135757 136513 137103 137118 137461 135102 136042 138124 138132 135927 137510 138260 138012 138058 137193 135986 135935 135953 138055 124303 135841 138497 135200 135201 135279 124061 135879 135229 136113 135990 138035 138214 137479 138156 124083 137532 137540 136077 124102 137314 135862 124116 135235 135117 135920 137295 136168 138087 137582 137592 138221 138112 135366 138084 137075 124115 135843 138057 138118 138061 135779 136224 124395 137130 137188 137131 137146 137662 135137 138071 138102 138486 136579 137388 137470 124007 137011 136280 138311 136286 137347 135109 137766 124384 138128 137638 137731 124383 138017 124394 137595 135144 135145 136362 138259 137245 137620 137335 137607 137617 136318 136234 138402 135151 135421 135760 136500 135217 137369 136031 136032 137421 135124 136084 137569 136026 137425 136479 135285 136338 136196 135245 135420 124051 136384 136387 136488 136256 135767 136408 136508 135182 137650 137668 136242 136383 135788 136517 135406 136043 137311 137320 137360 138163 135129 135416 138004 135222 136393 124268 137639 135302 135260 137736 138194 124273 138325 138358 135143 137645 135114 137093 136350 138193 135253 135772 138201 138250 135190 124378 137591 137438 135881 136614 136567 138104 135714 137656 138119 124302 138147 137239 138005 136089 138367 138397 135180 135184 135922 124119 136314 124703 137296 138015 136190 136197 136254 137458 138070 135813 136970 137229 124388 135791 137112 137218 124080 138230 138266 136561 138268 136505 124006 137244 137231 124118 135793 138346 135132 135148 138180 138480 137513 138458 138513 139012 137217 137224 135723 124111 136126 136217 135847 135281 135373 135196 124344 136557 136558 124286 137511 136391 137297 135909 136143 137403 139023 138357 138381 135384 136582 138340 136345 138188 137567 136459 136518 124314 136290 135233 135353 136594 135203 124056 137667 137579 137551 138051 136137 138190 135397 137518 136278 Additional Serial Numbers as of 10/4/23: 136450 135352 124201 124089 136548 136568 124015 136607 136586 136555
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0967-2022
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