Reported Jan 11, 2023 · Ongoing
Programmable Diagnostic Computer
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?
- Programmable Diagnostic Computer
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 1076456104056869010137Sensis Vibe Hemo 1100764104056869010199Sensis Vibe Combo 1100764204056869010205All units with software version VD12A - Amount recalled
- 2213 distributed worldwide; 638 US
Where it was sold
- Nationwide
Why it was recalled
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;
This product could cause temporary or reversible health problems — stop using it.
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