CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report

Sensis/ Sensis Vibe Hemo systems with VD12A recalled

Siemens Medical Solutions USA is recalling Sensis/ Sensis Vibe Hemo systems with VD12A, distributed nationwide in the US. The recall was initiated on 4 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021

Quantity recalled99 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1434-2021
FDA event ID: 87515
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 4 Mar 2021
FDA classified: 19 Apr 2021
Reported: 28 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

4 Mar 2021	Recall initiated by company
19 Apr 2021	Classified by FDA	+46 days
28 Apr 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Sensis/ Sensis Vibe Hemo systems with VD12A recalled?

Yes. Siemens Medical Solutions USA recalled Sensis/ Sensis Vibe Hemo systems with VD12A on 4 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1434-2021.

Why was it recalled?

Which lots are affected?

Serial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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