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Siemens Medical Solutions USA, Inc Recall 91240

Description: Programmable Diagnostic Computer

Siemens Medical Solutions USA, Inc Recall 91240 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0775-2023
Event ID91240
Event DescriptionProgrammable Diagnostic Computer
Product TypeDevices
DistributionDomestic 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
Quantity1969 distributed worldwide; 393 US
Recall ReasonThe 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 Classification20230111
Device Code InfoSystem Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe Hemo 11007641 04056869010199 Sensis Vibe Combo 11007642 04056869010205 All units with software version VD12A
Center Classification Date20221231
Recall Initiation Date20221116
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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