Use cautionMedical device recall · FDA · Published July 12, 2022
Siemens Sensis Combo Systems Recall: Risk of Patient Touch Leakage Current
Siemens recalls Sensis Combo systems with specific serial numbers due to potential patient touch leakage current and liquid spillage risks. Affected units include AXIOM Sensis models with serial numbers listed in the recall notice.
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens Sensis Combo Systems Recall: Risk of Patient Touch Leakage Current.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60371-siemens-sensis-combo-systems-recall-risk-of-patient-touch-leakage. Based on FDA recall #Z-1558-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1558-2022%22&limit=1).
The FDA announced on July 12, 2022, that Siemens Medical Solutions USA, Inc. is recalling AXIOM Sensis and Sensis Vibe Combo systems due to potential touch leakage current to patients or liquid spillage entering the Signal Input Box if mounting positions deviate. Owners should contact Siemens for a remedy.
How to tell if you have it
AXIOM Sensis, Combo 64 Material # 6623974
AXIOM Sensis, Hemo LOW Material # 6634633
AXIOM Sensis, Combo 32 Material # 6634641
AXIOM Sensis, EP 129 Material # 6634658
Sensis Material # 10764561
Sensis Vibe Combo Material # 11007642
The hazard
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table). In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since 2017-06-06. Other recent recalls include the Siemens ARTIS icono Ceiling Monitor Recall (2026-06-08), the Siemens ARTIS icono floor recall (2026-05-20), and the Siemens ARTIS Pheno VE30A/VE40A recall (2026-03-12). Other recent recalls of similar products include the ICU Medical Hotline Fluid Warming Set Recall (2026-06-24), the Spacelabs Ultraview SL Command Module Software Recall (2026-03-26), and the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03).
How to tell if you have this one
Check for the specific serial numbers listed in the recall notice (e.g., 6623974, 6634633, etc.) on your Sensis Combo system. The product is used for cardiac and interventional radiology procedures.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Mounting Position
Ensure the Signal Input Box is mounted correctly to avoid patient contact or liquid spills.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cambodia Cameroon Canada Chile China…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1558-2022 (July 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1558-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.