Siemens Medical Solutions USA, Inc Recall 91240
Description: Programmable Diagnostic Computer
Siemens Medical Solutions USA, Inc Recall 91240 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0775-2023 |
| Event ID | 91240 |
| Event Description | Programmable Diagnostic Computer |
| Product Type | Devices |
| 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 Yemen |
| Quantity | 1969 distributed worldwide; 393 US |
| Recall 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; |
| Device Classification | 20230111 |
| Device Code Info | System Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe Hemo 11007641 04056869010199 Sensis Vibe Combo 11007642 04056869010205 All units with software version VD12A |
| Center Classification Date | 20221231 |
| Recall Initiation Date | 20221116 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |