AXIOM Sensis, Computer, Diagnostic, Programmable
Medical device recall Z-2156-2017. Published in FDA’s Enforcement Report on May 31, 2017.
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 May 31, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4,095 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
4,095, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model no.: 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 Serial Numbers: 2052 3021 2272 20356 20020 20059 2563 2571 2581 2582 2589 2593 100018 100036 41021 6108 2041 3365 3381 3382 3460 8001 20056 2348 3411 3428 20380 20634 3112…
Every code shown here, 1,997 characters
Model no.: 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 Serial Numbers: 2052 3021 2272 20356 20020 20059 2563 2571 2581 2582 2589 2593 100018 100036 41021 6108 2041 3365 3381 3382 3460 8001 20056 2348 3411 3428 20380 20634 3112 3383 22417 61012 2264 2291 2336 2411 2601 22215 8060 2508 22365 2586 2587 2588 60301 3405 3406 3440 3407 3408 3437 22267 61084 3546 60410 60138 60412 2407 3156 40108 2016 2702 3046 3073 3126 21120 22603 2181 2200 2294 21334 20109 20127 20160 20161 20660 60110 3417 3564 61072 60147 3240 3318 60396 60426 22648 20111 3603 2060 2154 2155 2201 3037 3041 3166 3224 3226 3352 3534 3536 22688 2573 3246 3257 3258 20017 20046 22219 21033 60370 60372 2517 60125 60128 60060 60120 60127 60129 60134 60143 61083 2744 2520 2521 3239 21222 21226 21244 21255 3458 20599 22345 22357 22366 60062 22249 2506 2709 2739 3072 20102 20134 20137 20149 20314 21212 2552 3060 20062 20574 6024 2034 2035 2525 2447 2594 3366 60347 60348 2442 2444 2500 2501 61031 2025 21496 22011 22025 2276 2408 20628 20642 60473 61002 3040 40007 20014 42320 2578 3621 3622 3623 3649 3650 3651 3653 3655 3670 3671 3676 21323 22423 22427 20448 60079 22217 2290 3463 21078 21079 21258 41202 2562 60151 61061 20065 3503 3504 3526 3527 22658 61025 21034 21035 21043 61086 22336 60369 60308 3261 60312 2527 20084 2420 2395 22225 20105 20573 20575 3512 2394 2042 3344 4003 21475 22251 60040 20495 41017 42308 21037 21051 21052 21095 21100 21102 21438 22022 60351 20100 20104 6050 2282 2301 2331 2332 2515 8067 8068 2156 60023 60024 60025 6101 20321 3390 20045 20047 6208 3136 3333 20598 3677 2142 2714 8009 2266 2531 2533 21391 22708 60052 6033 2304 2310 3173 61047 61048 61054 61059 60468 60322 20431 20436 2439 21463 21466 6638 6639 6720 6734 3416 3418 3419 3420 21392 21393 21394 20433 22069 40011 2426 2203 60332 20360 3134 3169 3230 3231 3233 3255 3256 21300 6503 2385 2410 3091 3097 2526 3461 3462 3620 20049 20397 20363 3445 3448 3475 21332 20015 60474 3627 3629 20383 60022 60089 41019 21106 21112…
FDA’s list runs to 4,204 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.
Nationwide Distribution
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.
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 Apr 12, 2017.
- FDA classified it on May 23, 2017.
- FDA’s Enforcement Report published it on May 31, 2017.
- FDA terminated it on May 15, 2018.
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 4,204 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.