Wipro GE Healthcare Private Ltd.: Device Recall

Recall Details

Recall Number

Z-0213-2026

Classification

Class II

Product Type

Device

Recalling Firm

Wipro GE Healthcare Private Ltd.

Status

Ongoing

Date Initiated

09/05/2025

Location

Bengaluru, India

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

173 units

Reason for Recall

GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

Product Description

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

Distribution Pattern

Worldwide distribution.

Other Recalls by Wipro GE Healthcare Private Ltd.

• Class II: Risk 09/05/2025
  GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
• Class II: Risk 08/09/2024
  GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
• Class II: Risk 08/09/2024
  GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

View all recalls by Wipro GE Healthcare Private Ltd. →