Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 26, 2022
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc recalled 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 1100… - a moderate-severity action.
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 1100… was recalled by Siemens Medical Solutions USA, Inc in January 26, 2022. Reason: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD1…. Check the official notice for the remedy. Verify recall #Z-0499-2022 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD1….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- January 26, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0499-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0499-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on November 23, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 1047.
The documented reason for this recall is: 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 sp… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1047
Related Recalls
6
3 from same agency
Product description
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 for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0499-2022 |
| Date reported | January 26, 2022 |
| Date initiated | November 23, 2021 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 1047 |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0499-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1047.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0499-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0499-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 26, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.