Recall · FDA
Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc issued a Class II FDA recall (Z-0775-2023) initiated 2022-11-16: Programmable Diagnostic Computer
| Company | Siemens Medical Solutions USA, Inc |
|---|---|
| Recall number | Z-0775-2023 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2022-11-16 |
| Product | Programmable Diagnostic Computer |
| Reason | 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; |
FAQ
What did Siemens Medical Solutions USA, Inc recall?
Programmable Diagnostic Computer
Why was Siemens Medical Solutions USA, Inc's product 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; …