Reported Apr 28, 2021 · Terminated
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing…
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
Is this the product you have?
- Sensis/ Sensis Vibe Hemo
- systems with VD12A software as followsDedicated 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
- Lot codes and dates
- Serial NumbersAs of 8/24/22 (Updated)
99 of 99 codes
106611165714000140121412314312146031480414900149021501015130151351513615819158291590215903159041590815913159151591615917159201592315924159251592615927159281890018901100208100209100216100306100309102138102145102147102221102326103014103019103022103039103040103042103047103048103079103080103082103086103088103089103090103108103111
- Serial NumbersAs of 8/24/22 (Updated)
- Amount recalled
- 99 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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