# FDA recall Z-0775-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-11-16.

## Product

Programmable Diagnostic Computer

## Reason for recall

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;

## Distribution

Domestic distribution nationwide. Worldwide foreign distribution to Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Botswana Bulgaria Cambodia Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Djibouti Dominican Republic Ecuador Egypt El Salvador Fiji Finland France Germany Ghana Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Italy Ivory Coast (Cote d' Ivoire) Jordan Kazakhstan Kenya Kuwait Latvia Lebanon Libya Macedonia Madagascar Malaysia Mauritius Mexico Monaco Mongolia Montenegro Morocco Myanmar Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Philippines Poland Portugal Qatar Romania Rwanda Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sudan Sweden Switzerland Syria Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Uganda Ukraine United Arab Emirates United Kingdom Vietnam

## Key facts

- **Recall number:** Z-0775-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-16
- **Report date:** 2023-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0775-2023

## Citation

> AI Analytics. FDA recall Z-0775-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0775-2023. Source: US FDA. Licensed CC0.

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