ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI #: 4056869046877 Serial Numbers: 164011 164013 164018 164019 164021 164022 164024 164025 164026 164027 164028 164033 164034 164048 164049 164053 164054 164055 164057 164060 164061 164063 164064 164066 164068 164069 164071 164072 164073 164074 164075 164080 164083 164084 164086 164094 164095 164097 164098 164100 164105 164113 164115 164121 164124 164125 164134 164138 164140 164142 164152 164153 164155 164157 164158 164159 164160 164161 164163 164168 164171 164172 164173 164183 164184 164186 164187 164188 164189 164190 164196 164201 164202 164204 164205 164210 164211 164212 164213 164216 164227 164228 164231 164234 164240 164241 164242 164244 164250 164253 164263 164267 164269 164270 164275 164277 164279 164282 164287 164292 164293 164295 164297 164298 164299 164300 164303 164306 164311 164312 164315 164318 164319 164321 164322 164326 164328 164329 164330 164331 164332 164333 164338 164340 164344 164352 164353 164355 164359 164362 164366 164371 164377 164389 164391 164394 164397 164398 164399 164400 164403
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Product Codes/Lot Numbers:

UDI #: 4056869046877 Serial Numbers: 164011 164013 164018 164019 164021 164022 164024 164025 164026 164027 164028 164033 164034 164048 164049 164053 164054 164055 164057 164060 164061 164063 164064 164066 164068 164069 164071 164072 164073 164074 164075 164080 164083 164084 164086 164094 164095 164097 164098 164100 164105 164113 164115 164121 164124 164125 164134 164138 164140 164142 164152 164153 164155 164157 164158 164159 164160 164161 164163 164168 164171 164172 164173 164183 164184 164186 164187 164188 164189 164190 164196 164201 164202 164204 164205 164210 164211 164212 164213 164216 164227 164228 164231 164234 164240 164241 164242 164244 164250 164253 164263 164267 164269 164270 164275 164277 164279 164282 164287 164292 164293 164295 164297 164298 164299 164300 164303 164306 164311 164312 164315 164318 164319 164321 164322 164326 164328 164329 164330 164331 164332 164333 164338 164340 164344 164352 164353 164355 164359 164362 164366 164371 164377 164389 164391 164394 164397 164398 164399 164400 164403

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1311-2023

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