Severity
Low
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well
Reported: August 24, 2022 Initiated: July 12, 2022 #Z-1558-2022 399 units U.S. units
Siemens Medical Solutions USA, Inc issued this FDA Devices recall on August 24, 2022. Classified as Low severity (Class III). Approximately 399 units U.S. units are affected. The recall was issued because: The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mountin…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1558-2022) was formally reported on August 24, 2022, with the manufacturer initiating the action on July 12, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records indicate 399 units U.S. units are affected.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cam…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
399 units U.S.
Related Recalls
6
6 from same agency
Product Description
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Reason for Recall
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 399 units U.S.
- 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 Colombia Costa Rica Croatia Cuba Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Libya Luxembourg Macao Malaysia Maldives Mali Mauritius Mexico Moldova Montenegro Morocco Mozambique Myanmar Namibia Netherlands New Caledonia New Zealand Nigeria North Korea Norway Oman Pakistan Palestine, State of Panama Paraguay Peru Philippines Poland Portugal Qatar Romania Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sudan Suriname Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela, Bolivarian Republic of Vietnam Yemen
- Location
- Malvern, PA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1558-2022 |
| Date reported | August 24, 2022 |
| Date initiated | July 12, 2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Units affected | 399 units U.S. |
| 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 Can… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 399 units U.S..
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2022. Severity: Low. Recall number: Z-1558-2022.
Where was the recalled product distributed? ▼
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 Colombia Costa Rica Croatia Cuba Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Libya Luxembourg Macao Malaysia Maldives Mali Mauritius Mexico Moldova Montenegro Morocco Mozambique Myanmar Namibia Netherlands New Caledonia New Zealand Nigeria North Korea Norway Oman Pakistan Palestine, State of Panama Paraguay Peru Philippines Poland Portugal Qatar Romania Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sudan Suriname Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela, Bolivarian Republic of Vietnam Yemen.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1558-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).