Recall Z-0775-2023
Siemens Medical Solutions USA, Inc · initiated November 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Programmable Diagnostic Computer
Codes / lots: System Model # UDI-DI # Sensis 10764561 04056869010137 Sensis Vibe Hemo 11007641 04056869010199 Sensis Vibe Combo 11007642 04056869010205 All units with software version VD12A
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;
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0775-2023
- Initiated
- November 16, 2022
- Posted by FDA
- January 1, 2023
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 2213 distributed worldwide; 638 US
- 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…
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA