FDA Medical devices recall ·
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with… recall
- Recall number
- Z-0213-2026
- Date
- (initiated September 5, 2025)
- Company / brand
- Wipro GE Healthcare Private Ltd.
122 Part 1, Bengaluru, India - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 173 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
Why was it recalled?
Carescape Central Station (CSCS), software version V3.0.5, 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00195278343512, Serial Numbers: STU25210418SA, STU25210417SA, STU25210419SA, STU25250440SA, STU25250439SA, STU25260447SA, STU25210407SA, STU25210406SA, STU24200003SA, STU24200006SA, STU24200005SA, STU24200004SA, STU23240015SA, STU24240019SA, STU24240020SA, STU24240007SA, STU24240022SA, STU24240021SA, STU24330020SA, STU24240014SA, STU24240013SA, STU24330019SA, STU24330022SA, STU24330016SA, STU24240005SA, STU24240008SA, STU24240012SA, STU24330018SA, STU24330021SA, STU24330017SA, STU23160011SA, STU23240007SA, STU24310001SA, STU25210433SA, STU25210432SA, STU25200390SA, STU25200392SA, STU25200391SA, STU25200399SA, STU25200397SA, STU25200395SA, STU25200393SA, STU25200398SA, STU25200396SA, STU25250438SA, STU25270475SA, STU25270456SA, STU25270468SA, STU25270458SA, STU25270466SA, STU25270476SA, STU25270469SA, STU25270473SA, STU25270459SA, STU25270474SA, STU25270467SA, STU25210430SA, STU25210429SA, STU25180343SA, STU25190347SA, STU25190348SA, STU24200007SA, STU25190360SA, STU25240436SA, STU25190361SA, STU25190362SA, STU25190363SA, STU25240437SA, STU25190359SA, STU24510027SA, STU24510032SA, STU24510010SA, STU24510020SA, STU24510017SA, STU24510026SA, STU24510018SA, STU24510024SA, STU24510025SA, STU24510031SA, STU24510011SA, STU24510029SA, STU24510023SA, STU24510030SA, STU24510021SA, STU24510019SA, STU24510022SA, STU25190350SA, STU25200388SA, STU25200389SA, STU25210412SA, STU25190349SA, STU25190381SA, STU25190376SA, STU25190383SA, STU25190374SA, STU25190367SA, STU25190372SA, STU25190
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0213-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.