Recall archive / FDA device enforcement
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. ... — FDA record Z-0499-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 23, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.
- Reason
- Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1047
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0499-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1. Sensis- 10764561; UDI: 04056869010137; Serial Numbers: 103493, 103432, 103466 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199; Serial Numbers: 103137, 103144, 103453, 103108, 103111, 103047, 103048, 103171, 103182, 103193, 103301, 103170, 103223,, 103225, 103247, 103313, 103315, 103196, 103198, 103166, 103173, 103177, 103184, 103186, 103199, 102326, 103139, 103161, 103167, 103168, 103172, 103178, 100263, 103424, 103319, 103320, 103321, 103323, 103325, 103328, 103330, 103333, 103334, 103335, 103344, 100216, 103337, 100416, 102008, 103413, 101083, 100208, 100209, 102138, 102145, 102147, 103160, 103314, 102199, 103079, 102221, 103123, 103124, 103131, 100163, 100306, 100309, 103300, 101099, 101100, 101101, 103265, 100422, 103019, 103331, 103362, 103393, 103402, 103419, 103252, 103261, 103267, 103269, 103270, 103276, 103277, 103280, 103281, 103022, 103381, 103194 103145, 103148, 103152, 100345, 102183, 103345, 103368, 103415, 103416, 103245, 103249, 103250, 103264, 103080, 103082, 103086, 103088, 103089, 103090, 100231, 103431, 103306, 103341, 103114, 100070, 100071, 100074, 102155, 102157, 103040, 103042, 103039, 102174, 102182, 103130, 103200, 103234, 103116, 103117, 103119, 103288, 103008, 103216, 103465, 103189, 103208, 102010, 102295, 102296, 102302, 100006, 100005, 103352, 103283, 103308, 103310, 103115, 103244, 103246, 103014, 103242, 102143, 103359, 103274, 103437 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205; Serial Numbers: 123021, 123004, 123047, 123053, 122011 ***Updated 1/18/22*** SENSIS Vibe Hemo, Serial #103185 ***Updated 2/24/22*** SENSIS Vibe Hemo Serial #103290 103510 103451 103461 103444 103450 103448 103445 103442 103449 103439 103457 SENSIS Vibe Combo Serial #123055 123056 123058 The following serial numbers have been removed from the scope of this recall: SENSIS Vibe Hemo Serial #103301 103424 ***Updated 8/5/22*** The following serial numbers have been added to the recall: SENSIS Vibe Combo Serial numbers 103307, 103312 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 26, 2022
- Recall initiation date
- Nov 23, 2021
- Center classification date
- Jan 14, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.