Programmable Diagnostic Computer — Class II medical device recall Z-0775-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-01-11, distributed nationwide. The firm will be performing a software update to address a software error which affects the listed products. T
| Recall number | Z-0775-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-11-16 |
| Classified | 2022-12-31 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IN, IQ, IR, IT, JO, KE, KR, KW, LB, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, VN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869010137, 04056869010199, 04056869010205 |
Product
Programmable Diagnostic Computer
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;
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0775-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.