Siemens Medical Solutions USA, Inc Programmable Diagnostic Computer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Programmable Diagnostic Computer
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
System Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe Hemo 11007641 04056869010199 Sensis Vibe Combo 11007642 04056869010205 All units with software version VD12A
Siemens Medical Solutions USA, Inc is recalling Programmable Diagnostic Computer due to The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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;
Recommended Action
Per FDA guidance
On November 16, 2022, the firm notified customers with an Urgent Medical Device Correction letter delivered electronically via EchoSign. Customers were informed of the 4 software issues. Siemens will update the software in affected systems to resolve the issues. The firm's service organization will contact customers to arrange a date to perform the corrective action. You may contact the firm's service organization for an earlier appointment at 1--800-888-7436.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026