Sign in Sign up

Wipro GE Healthcare Private Ltd. FDA Recalls

10 recalls on file across devices, 6 of them Class I and 10 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; MClass IISep 5, 2025Carescape Central Station (CSCS), software version V3.0.5, c	Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot c	Class IIDevices	Sep 5, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; MClass IISep 5, 2025Carescape Central Station (CSCS), software version V3.0.5, c	Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot c	Class IIDevices	Sep 5, 2025
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; Class IIAug 9, 2024GE HealthCare has become aware that complete electrical safe	GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing	Class IIDevices	Aug 9, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled Class IIAug 9, 2024GE HealthCare has become aware that complete electrical safe	GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing	Class IIDevices	Aug 9, 2024
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-85Class IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822Class IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500Class IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000Class IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M116Class IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TRClass IDec 26, 2023GE HealthCare has become aware that the bedside panel of Car	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000	Class IDevices	Dec 26, 2023

Related datasets

FDA ApprovalsNew drugs approved, and devices cleared for sale.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.