AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974
Medical device recall Z-1558-2022. Published in FDA’s Enforcement Report on Aug 24, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 24, 2022. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 399 units U.S. how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
399 units U.S., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1.Sensis 10764561 UDI-DI:04056869010137 2. Sensis Vibe Combo 11007642 UDI-DI: 04056869010205 Serial Numbers: 2022 2025 2032 2060 2113 2139 2154 2155 2186 2187 2201 2205 2224 2225 2227 2229 2269 2272 2276 2282 2291 2293 2294 2331 2332 2349…
Every code shown here, 1,998 characters
1.Sensis 10764561 UDI-DI:04056869010137 2. Sensis Vibe Combo 11007642 UDI-DI: 04056869010205 Serial Numbers: 2022 2025 2032 2060 2113 2139 2154 2155 2186 2187 2201 2205 2224 2225 2227 2229 2269 2272 2276 2282 2291 2293 2294 2331 2332 2349 2350 2352 2403 2408 2425 2428 2442 2444 2500 2501 2515 2520 2521 2532 2552 2563 2576 2578 2581 2589 2608 2629 2744 3014 3015 3021 3037 3038 3041 3049 3050 3051 3057 3059 3060 3069 3075 3091 3097 3101 3103 3112 3128 3129 3134 3136 3140 3142 3166 3205 3206 3224 3226 3316 3321 3333 3352 3383 3390 3405 3406 3407 3408 3417 3432 3434 3437 3440 3464 3472 3475 3529 3534 3536 3564 3641 3642 3650 3653 3655 3660 3671 3676 4003 6101 6103 6110 6208 6622 6625 6631 6702 6727 8067 8068 20004 20015 20016 20023 20026 20045 20047 20048 20056 20062 20065 20109 20127 20139 20161 20162 20319 20321 20380 20383 20385 20391 20392 20399 20407 20430 20448 20466 20525 20538 20546 20556 20557 20561 20573 20574 20575 20585 20598 20606 20618 20622 20660 21000 21034 21035 21037 21043 21051 21052 21056 21074 21076 21077 21095 21096 21098 21100 21102 21106 21109 21112 21226 21244 21297 21332 21334 21345 21346 21363 21383 21384 21388 21391 21399 21438 21452 21498 22000 22022 22037 22051 22217 22249 22251 22252 22267 22282 22312 22336 22341 22345 22357 22366 22406 22415 22423 22427 22436 22437 22438 22461 22462 22474 22480 22490 22512 22522 22523 22526 22528 22605 22612 22619 22623 22627 22628 22646 22648 22651 22652 22663 22667 22669 22670 22671 22681 22682 22688 22708 22720 40011 40012 40108 41017 41019 41021 41202 42109 42209 42308 60020 60022 60023 60024 60025 60040 60052 60058 60060 60062 60065 60079 60087 60089 60095 60110 60111 60116 60120 60123 60125 60127 60128 60129 60130 60134 60138 60143 60146 60147 60154 60166 60167 60171 60308 60311 60312 60322 60323 60325 60347 60348 60355 60369 60370 60372 60395 60410 60412 60427 60436 60444 60453 60468 60473 60474 60480 60483 61002 61008 61009 61014 61030 61031 61048 61061 61064 61071 61072 61081 61083 61084 61086…
FDA’s list runs to 2,394 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 12, 2022.
- FDA classified it on Aug 18, 2022.
- FDA’s Enforcement Report published it on Aug 24, 2022.
- FDA terminated it on Nov 7, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,394 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.