Sensis/ Sensis Vibe systems with software VD1X as follows
Medical device recall Z-0226-2022. Published in FDA’s Enforcement Report on Nov 24, 2021.
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 Nov 24, 2021. 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
- 403 units 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?
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
403 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022…
Every code shown here, 2,000 characters
Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022 101029 101031 101032 101036 18903 15945 15946 103359 15931 100263 103424 15953 103274 15941 15942 103319 103320 103321 103323 103325 103328 103330 103333 103334 103335 103344 100216 103337 15514 15515 100154 100156 100157 14803 14804 18502 15544 15545 100416 102008 103413 15561 101082 101083 101084 18902 14603 100208 100209 102138 103437 15560 101090 102019 102021 102025 102029 15559 101088 15819 15820 102145 102147 103160 15539 100346 100349 103314 102199 15830 102323 102324 102325 15832 15833 103079 122042 123004 15005 15147 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 122006 122026 102214 102216 102219 102222 102272 101096 102181 102242 102068 102069 102078 102080 102093 102097 15828 15829 102221 103123 103124 103131 100163 100165 15135 15136 100306 100309 15552 15553 101045 101052 101053 101054 101056 101059 101063 101064 103300 15564 15565 101099 101100 101101 15556 15557 101060 101068 101069 101070 101071 101072 103265 14602 100064 15546 14611 100422 14906 103307 103312 103019 10654 11657 14122 14123 103331 103362 103393 103402 103419 103252 103261 103267 103269 103270 103276 103277 103280 103281 103022 100279 103381 15543 15551 100408 100410 100411 100412 101043 102162 122029 103194 103145 103148 103152 15920 15537 15538 100345 123047 15836 15837 102285 102286 102338 102183 15943 15948 103345 103368 103415 103416 123053 15123 103245 103249 103250 103264 15949 15904 103080 103082 103086 103088 103089 103090 15530 100231 103290 15804 102030 102031 102304 101094 18600 15547 15548 101008 101093 15821 15523 100175 100176 102226 101097 15935 15936 103306 103341 15909 102269 102273 102276 102278 102279 103114 14809 14810 102283 15823 15824 102193 15803 15809 15506 15507 100070 100071 100074 102155…
FDA’s list runs to 2,787 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
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 Oct 5, 2021.
- FDA classified it on Nov 16, 2021.
- FDA’s Enforcement Report published it on Nov 24, 2021.
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 2,787 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.