Chrysalis Intelligence · Sponsors · Ge Medical Systems Israel

Ge Medical Systems Israel

Tirat Hacarmel, IL · 1 510(k) clearances · 1 recalls

Total clearances
1
2025-06-12 → 2025-06-12
Last 12 months
0
Product codes
1
Most recent
2025-06-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KPS System, Tomography, Computed, Emission Class II Radiology 1 2025-06-12
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2023-09-06
DateSeverityStatusRecall # ProductCodeReason
2023-09-06 Class II Ongoing Z-2652-2023 Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pul… Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detach…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-06-12 K251153 Aurora KPS Class II Radiology