FEI 3006948427
Z-systems Ag
Werkhofstrasse 5, Oensingen Solothurn, CH
MDR events3,891All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 product codes
Recent MDR events
3,891 on file
- Z5Jun 25, 2026Malfunction3006948427-2026-00226
- Z5Jun 25, 2026Malfunction3006948427-2026-00228
- Z5Jun 25, 2026Malfunction3006948427-2026-00229
- Z5Jun 25, 2026Malfunction3006948427-2026-00227
- Z5Jun 25, 2026Malfunction3006948427-2026-00209
- Z5Jun 25, 2026Malfunction3006948427-2026-00236
- Z5Jun 25, 2026Malfunction3006948427-2026-00231
- Z5Jun 25, 2026Malfunction3006948427-2026-00235
- Z5Jun 25, 2026Malfunction3006948427-2026-00230
- Z5Jun 25, 2026Malfunction3006948427-2026-00232
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3006948427.
FDA inspections
1 on file
- Official Action Indicated (OAI)Apr 25, 2024
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(f)Apr 25, 2024
Design verification - output does not meet input requirement
- 21 CFR 820.80(b)Apr 25, 2024
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Apr 25, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(d)Apr 25, 2024
Evaluation, timeliness, identification
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.