Sensis, Programmable Diagnostic Computer
Medical device recall Z-1243-2022. Published in FDA’s Enforcement Report on Jun 15, 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 Jun 15, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 443 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?
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
443, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41021 6623974 6110 6623974 6622 6623974 6727 6634633 3021 6634633 2272 6634633 2563 6634633 2589 6634633 20380 6634633 3112…
Every code shown here, 1,998 characters
UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41021 6623974 6110 6623974 6622 6623974 6727 6634633 3021 6634633 2272 6634633 2563 6634633 2589 6634633 20380 6634633 3112 6634633 2291 6634633 3405 6634633 3406 6634633 3440 6634633 3407 6634633 3408 6634633 3437 6634633 22267 6634633 21334 6634633 3417 6634633 3564 6634633 2060 6634633 2154 6634633 2155 6634633 2201 6634633 3037 6634633 3038 6634633 3041 6634633 3166 6634633 3224 6634633 3226 6634633 3352 6634633 3534 6634633 3536 6634633 20102 6634633 20134 6634633 20137 6634633 20149 6634633 20314 6634633 22688 6634633 2520 6634633 2521 6634633 2506 6634633 2709 6634633 2739 6634633 3072 6634633 21212 6634633 2552 6634633 2744 6634633 3060 6634633 20062 6634633 20574 6634633 2442 6634633 2444 6634633 2500 6634633 2501 6634633 2025 6634633 2276 6634633 2408 6634633 3622 6634633 3650 6634633 3653 6634633 3670 6634633 3671 6634633 3676 6634633 2578 6634633 22427 6634633 20448 6634633 21034 6634633 21035 6634633 21043 6634633 22336 6634633 21037 6634633 21051 6634633 21052 6634633 21095 6634633 21100 6634633 21102 6634633 21438 6634633 22022 6634633 2515 6634633 3390 6634633 2282 6634633 2331 6634633 2332 6634633 20321 6634633 20045 6634633 20047 6634633 3333 6634633 20598 6634633 2203 6634633 3091 6634633 3097 6634633 3059 6634633 3472 6634633 22671 6634633 2434 6634633 20525 6634633 20556 6634633 20557 6634633 2022 6634633 2032 6634633 2629 6634633 20392 6634633 22406 6634633 20594 6634633 20637 6634633 22611 6634633 20162 6634633 22612 6634633 3319 6634633 21399 6634633 22037 6634633 21384 6634633 21395 6634633 21452 6634633 3475 6634633 21332 6634633 22345 6634633 22357 6634633 22366 6634633 2403 6634633 20407 6634633 20033 6634633 22509 6634633 3075 6634633 2225 6634633 20430 6634633 22282 6634633 2113 6634633 2186 6634633 2187 6634633 3049 6634633 3050 6634633 22461 6634633 22462 6634633 22415 6634633 22312 6634633 22663 6634633 22667 6634633…
FDA’s list runs to 7,316 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.
Domestic distribution nationwide.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 13, 2022.
- FDA classified it on Jun 6, 2022.
- FDA’s Enforcement Report published it on Jun 15, 2022.
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 7,316 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
-
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.