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Use caution Medical device recall · FDA · Published February 2, 2023

Siemens ARTIS pheno Systems with Certain Tables May Cause Patient Injury

Siemens Healthineers recalls ARTIS pheno systems with specific Siemens Healthineers or Trumpf/MAQUET tables due to risk of patient or staff injury from unintended table movement.

🇺🇸 FDA recall #Z-1311-2023Medical deviceSiemens Healthineers ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens Healthineers is recalling ARTIS pheno systems that use certain Siemens Healthineers or Trumpf/MAQUET tables. The system may not detect unintended table movement, which could injure patients, staff, or equipment. Read more at govinfonow.com/recall/58963-siemens-artis-pheno-systems-with-certain-tables-may-cause-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/58963-siemens-artis-pheno-systems-with-certain-tables-may-cause-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1311-2023

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“Siemens ARTIS pheno Systems with Certain Tables May Cause Patient Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58963-siemens-artis-pheno-systems-with-certain-tables-may-cause-patient. Based on FDA recall #Z-1311-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2023%22&limit=1).

The FDA announced on Feb. 2, 2023, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno fluoroscopic X-ray systems due to a hazard of unintended table movement. The agency stated the system may not detect incorrect direction during such movements.

How to tell if you have it

  • Brand: Siemens Healthineers
  • Product: ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system
  • Material #: 10849000
  • 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
  • Units affected: 141 units US

The hazard

According to the FDA, in the event of any unintended table movement, the system may not detect the incorrect direction. This failure could lead to the injury of a patient, staff member, operator, or equipment.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls on record since June 6, 2017. Other recent recalls include the Siemens ARTIS icono Ceiling Monitor Recall for loose screws (June 8, 2026), the Siemens ARTIS icono floor recall for loss of movement capability (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall for inaccurate 3D scans due to radiation exposure (March 12, 2026). Other recent recalls of similar products include the Philips Azurion Systems potential safety issue with table movements (April 28, 2026), the Philips Azurion 5 M12 System Software Recalls for unexpected table movement risk (Jan. 26, 2026), and the Philips Azurion 3 M15 System Recall for unexpected table movement risk (Jan. 26, 2026).

How to tell if you have this one

Check for the serial numbers listed in the recall notice: 164011, 164013, 164018, and other specific numbers provided in the record. The system uses either a Siemens Healthineers table or a Trumpf/MAQUET table-A Fluoroscopic X-Ray system.

  • Brand
    Siemens Healthineers
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Table Serial Numbers

    Verify if your system's table has a serial number listed in the recall notice (e.g., 164011, 164013, etc.).

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Feb 2, 202312. FDA classified it Class II: Mar 30, 202323. Published in FDA’s Enforcement Report: Apr 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using the system immediately?

The recall does not require immediate stop use; however, you should check if your system's table has a serial number in the list provided to assess risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1311-2023 (February 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1311-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA