Instrumentarium Dental Express SOLID STATE X-RAY IMAGER — Class II medical device recall Z-0842-2020
Terminated recall by Palodex Group Oy, reported 2020-01-29, distributed in PA, WI. Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-
| Recall number | Z-0842-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Palodex Group Oy, Tuusula, Finland |
| Recall initiated | 2020-01-07 |
| Classified | 2020-01-23 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2024-04-15 |
| Distributed | PA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DZ, EC, ES, FI, FR, GB, GR, HU, IL, IN, IT, JP, KR, KW, MT, MY, NL, NO, NZ, OM, PK, PL, QA, RO, RS, SA, SE, SG, SI, TH, TR, TW, VN |
| Quantity | 4,563 total |
| Reason classes | specification failure, device malfunction |
Product
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Reason for recall
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
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-0842-2020. 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.