The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0499-2022·Announced 2022-01-26

FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error

Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The software malfunction can prevent a critical diagnostic measurement (cardiac output) during invasive cardiac procedures. Per the rubric, this qualifies as High severity because it represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions is recalling three models of the Sensis cardiac diagnostic recording system: Sensis (material #10764561), Sensis Vibe Hemo (material #11007641), and Sensis Vibe Combo (material #11007642). These systems support hemodynamic catheterizations and electrophysiology studies in cardiac, interventional radiology, and surgical applications. Approximately 1,047 affected devices have been distributed nationwide.

A software error in version VD12A can prevent the cardiac output (CO) measurement using the Thermodilution method from functioning under certain sporadic circumstances. This creates a potential hazard to patients, operators, and equipment during invasive cardiac procedures. The FDA classified this as a Class II recall.

The affected systems have been distributed nationwide across multiple U.S. states and territories. Specific serial numbers for each affected model have been identified by the manufacturer and documented by the FDA.

Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for instructions regarding the affected devices and remediation of the software issue.

The recalled product

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…
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Cardiac Diagnostic Equipment
Hazard
Affected units
1,047

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

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