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Class IIOngoingZ-0213-2026

Wipro GE Healthcare Private Ltd. recalls GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version…

Wipro GE Healthcare Private Ltd.Bengaluru, IndiaReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 information

GTIN
00195278343512
Serial #
STU25210418SA, STU25210417SA, STU25210419SA, STU25250440SA, STU25250439SA, STU25260447SA — +167 moreShow all
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

What the firm is doing

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/05/2025, by letter delivered via traceable means. The notice explained the issues and requested the following: "Actions to be taken by Customer/User Pending correction by GE HealthCare, you can continue to use your device by following the instructions below. 1. Determine the number of central stations that are connected to the network including those in any offsite Central Monitoring Unit. 2. Ensure the number of connected central stations are fewer than 118 or more than 120. If you need assistance completing steps 1 or 2, please contact GE HealthCare Service or your local Service Representative. Note: Any versions prior to CSCS V3.0.5 are not affected by this issue. Ensure all users are aware of, understand, and follow these instructions. Please retain this document for your records. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

DistributionShow details

Worldwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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