FDA Device recall Z-0775-2023
Programmable Diagnostic Computer
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Programmable Diagnostic Computer by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0775-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-16 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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;
Identifiers
| code_info | System Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe He…System Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe Hemo 11007641 04056869010199 Sensis Vibe Combo 11007642 04056869010205 All units with software version VD12A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0775-2023%22
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