Reported Jan 26, 2022 · Ongoing
1. Sensis, material # 10764561; UDI
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
1. Sensis, material # 10764561; UDI
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 04056869010137 | 04056869010137 2. Sensis Vibe Hemo, material # 11007641 |
| 2 | 04056869010199 | UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642 |
| 3 | 04056869010205 | 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. |
- Lot codes and dates
- 1. Sensis- 10764561
- UDI04056869010137
- Serial Numbers
103493103432103466 2. Sensis Vibe Hemomaterial # 11007641
- UDI04056869010199
- Serial Numbers
156 of 156 codes
103137103144103453103108103111103047103048103171103182103193103301103170103223103225103247103313103315103196103198103166103173103177103184103186103199102326103139103161103167103168103172103178100263103424103319103320103321103323103325103328103330103333103334103335103344100216103337100416102008103413101083100208100209102138102145102147103160103314102199103079
- UDI04056869010205
- Serial Numbers123021, 123004, 123047, 123053, 122011 ***Updated 1/18/22*** SENSIS Vibe Hemo, Serial #103185 ***Updated 2/24/22*** SENSIS Vibe Hemo Serial #103290SENSIS Vibe Combo Serial #123055 123056 123058 The following serial numbers have been
103510103451103461103444103450103448103445103442103449103439103457
- removed from the scope of this recallSENSIS Vibe Hemo Serial #103301 103424 ***Updated 8/5/22*** The following serial
- numbers have been added to the recall
SENSIS Vibe Combo Serial numbers 103307103312
- Amount recalled
- 1047
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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