—#197321

Product

Programmable Diagnostic Computer

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K150493
Affected lot / 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

Why it was 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; 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;

Root cause (FDA determination)

Software design

Action the firm took

On November 16, 2022, the firm notified customers with an Urgent Medical Device Correction letter delivered electronically via EchoSign. Customers were informed of the 4 software issues. Siemens will update the software in affected systems to resolve the issues. The firm's service organization will contact customers to arrange a date to perform the corrective action. You may contact the firm's service organization for an earlier appointment at 1--800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-11-16
Posted by FDA: 2023-01-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197321. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.