Programmable Diagnostic Computer
FDA device recall Z-0775-2023 · posted 2023-01-01 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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;
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 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 Bots
- Date initiated
- 2022-11-16
- Date posted
- 2023-01-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |