Reported Jun 15, 2022 · Ongoing
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…
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 · 19355-1418
Is this the product you have?
- Sensis, Programmable Diagnostic Computer, Model Nos.
6623974663463366346586648153664816110140973107645611076550210910620
- Lot codes and dates
- UDI-DI04056869010137 Material Serial***Update 8/31/22 - the following units have been removed from the scope of this correction ***
886 of 886 codes
66239744010866239744120266239744101766239744230866239746101662397441021662397461106623974662266239746727663463330216634633227266346332563663463325896634633203806634633311266346332291663463334056634633340666346333440663463334076634633340866346333437663463322267663463321334663463334176634633356466346332060663463321546634633215566346332201
***Updated 11/9/22 - The following systems have been added to this correction*** 6634633 3136 10140973 13253 ***Updated 1/13/23 - Added the following system*** Material Serial 6623974 4232096 of 96 codes
66346332031466346332010266346332014966346332506663463327096634633273966346333072663463321212663463336226634633367066346333676664816118103664816118104107645616123010764561612326634633243410764561610881076550215130663463320594663463320637663463322611663463333191076550215146107655021500166346332003366346332250910140973132726648161181051076456161234664815316005
- UDI-DI04056869010137 Material Serial
- Amount recalled
- 443
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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