CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop recalled

Wipro GE Healthcare Private is recalling GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 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 recalled173 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0213-2026
FDA event ID: 97646
Recalling firm: Wipro GE Healthcare Private, Bengaluru
Classification: Class II
Status: Ongoing
Recall initiated: 5 Sep 2025
FDA classified: 21 Oct 2025
Reported: 29 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

5 Sep 2025	Recall initiated by company
21 Oct 2025	Classified by FDA	+46 days
29 Oct 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97646

This product is part of a recall event; the main page for the event is GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop recalled.

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025	CLASS II	GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop recalled	Wipro GE Healthcare Private	Device Malfunction

More recalls from Wipro GE Healthcare Private

All 10

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Device	CLASS II	GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop recalled	Wipro GE Healthcare Private	Device Malfunction
2 Oct 2024Device	CLASS II	GE Giraffe Warmer recalled by Wipro GE Healthcare Private	Wipro GE Healthcare Private	Packaging Defects
2 Oct 2024Device	CLASS II	GE Panda iRES Warmer recalled by Wipro GE Healthcare Private	Wipro GE Healthcare Private	Packaging Defects
21 Feb 2024Device	CLASS I	GE Healthcare neonatal incubator recalled by Wipro GE Healthcare Private	Wipro GE Healthcare Private	Other	N/A
21 Feb 2024Device	CLASS I	GE Healthcare Lullaby Incubator recalled by Wipro GE Healthcare Private	Wipro GE Healthcare Private	Other	N/A

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide