GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M
Summary
The FDA issued a Class II for GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software v by Wipro GE Healthcare Private Ltd.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0213-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
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
Lot/Code Info: 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, STU25190379SA, STU25190368SA, STU25190352SA, STU25190358SA, STU25190370SA, STU25190366SA, STU25190355SA, STU25190354SA, STU25190382SA, STU25190380SA, STU25190371SA, STU25190377SA, STU25190353SA, STU25190351SA, STU25190364SA, STU25190357SA, STU25190384SA, STU25190369SA, STU25190373SA, STU25190356SA, STU25190365SA, STU25190378SA, STU25190385SA, STU25210410SA, STU25210411SA, STU25210409SA, STU25230435SA, STU25180346SA, STU25180344SA, STU25180345SA, STU25210413SA, STU25210414SA, STU25210423SA, STU25210431SA, STU25210415SA, STU25270453SA, STU25260450SA, STU25260451SA, STU25290488SA, STU25210408SA, STU25210400SA, STU25270454SA, STU25210404SA, STU25210421SA, STU25270464SA, STU25210420SA, STU25270462SA, STU25210425SA, STU25270461SA, STU25210426SA, STU25210428SA, STU25210427SA, STU25270463SA, STU25270460SA, STU24460058SA, STU24460059SA, STU24460071SA, STU24460060SA, STU25200387SA, STU25210401SA, STU25200386SA, STU25210424SA, STU25270457SA, STU25270465SA, STU25300492SA, STU25210402SA, STU25210403SA, STU25250446SA, STU25210422SA, STU25210405SA, STU25260449SA, STU25290481SA, STU25290482SA, STU25290483SA, STU25290484SA, STU25210416SA.
Quantity Affected: 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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-05
Company
Bengaluru
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wipro GE Healthcare Private Ltd. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wipro GE Healthcare Private Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wipro GE Healthcare Private Ltd. have FDA actions?
Wipro GE Healthcare Private Ltd. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0213-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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