Reported Sep 9, 2020 · Terminated
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool…
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?
- Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
- Lot codes and dates
- Serial Numbers
111 of 111 codes
100413100414100417101016101017101019101020101022101029101031101036100263100416102008101083102138102019102021102025102029102145102147100346100349102199100095100097100103100115100116100117100120100121102158102167102168102172102272102068102069102078102080102093102221100163100165100306100309101056101099101100101101101060101068101069101070101071101072100064100422
- Expanded S/N11007641 11007641 11007641 ***9/28/20 Expanded S/N*** 103053 103040 103042 103008
- Serial Numbers
- Amount recalled
- 110 units US
Where it was sold
- Nationwide
Why it was recalled
The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost
This product could cause temporary or reversible health problems — stop using it.
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