MedFDAWatch
← Back to Medical Device Explorer

SPACELABS HEALTHCARE INC

ICS · General and Plastic Surgery

510(k): 0 Recall: 1 UDI: 0 MAUDE: 0 Class.: 0

Related Cybersecurity Alerts

Medline Industries, LP — Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258
HIGH · FDA · 2026-08-31
Medline Industries, LP — Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116
HIGH · FDA · 2026-08-31
Edan Diagnostics — Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The d
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: Th
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s P
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Pr
HIGH · FDA · 2025-10-24
Edan Diagnostics — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The i
HIGH · FDA · 2025-10-24

Recalls (1)

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
2019-01-28

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.