Wipro GE Healthcare Private Ltd.
Bangalore, IN
WIPRO GE HEALTHCARE PRIVATE LTD appears in FDA device records in Bangalore, IN. FDA records list 5 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Wipro GE Healthcare Private Ltd. between 2010 and 2013. The busiest year on record is 2012, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL | MOS | Substantially Equivalent | |
| K121625 | LULLABY TM WARMER | FMT | Substantially Equivalent | |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | LBI | Substantially Equivalent | |
| K110556 | MINI TELEMETRY SYSTEM | HGM | Substantially Equivalent | |
| K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613936 | 1000571342 | WIPRO GE HEALTHCARE PRIVATE LTD | 122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka 560 066 IN | 2026 | |
| 3007734888 | 3007734888 | WIPRO GE HEALTHCARE PRIVATE Ltd. | 122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO, BANGALORE Karnataka 560066 IN | 2026 | and 18 more, listed in full below |
| 9617277 | 3003190524 | Wipro GE Healthcare Private Ltd. | 4, Kadugodi Industrial Area, Bangalore Karnataka 560067 IN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- FSDBinder, Abdominal
- OBJCatheter, Ultrasound, Intravascular
- MOSCoil, Magnetic Resonance, Specialty
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- FMZIncubator, Neonatal
- LHOInstrument, Quality-Assurance, Radiologic
- IKYMattress, Flotation Therapy, Non-Powered
- HELMonitor, Heart Rate, Fetal, Ultrasonic
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture
- QFMRadiological Computer-Assisted Prioritization Software For Lesions
- FRWScale, Patient
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- FOXStand, Infusion
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- KPSSystem, Tomography, Computed, Emission
- IZLSystem, X-Ray, Mobile
- ITXTransducer, Ultrasonic, Diagnostic
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- ITOTwister, Brace Setting
- LBIUnit, Neonatal Phototherapy
- OSPUterine Electromyographic Monitor
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0214-2026 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube | 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. | Class II | Open, Classified | |
| Z-0213-2026 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube | 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. | Class II | Open, Classified | |
| Z-3081-2024 | GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits. | Class II | Open, Classified | |
| Z-3080-2024 | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits. | Class II | Open, Classified | |
| Z-0962-2024 | GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified | |
| Z-0961-2024 | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified | |
| Z-0960-2024 | GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified | |
| Z-0959-2024 | GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850 | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified | |
| Z-0958-2024 | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified | |
| Z-0957-2024 | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000 | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain