Recall Z-0775-2023 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Programmable Diagnostic Computer
| Date | Jan 1, 2023 (initiated Nov 16, 2022) |
| Status | Open, Classified |
| 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 con |
| Root cause | Software design |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |