Wipro GE Healthcare Private, Ltd.
Wipro GE Healthcare Private, Ltd. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2013, with 10 FDA device recalls on record.
Top product codes for Wipro GE Healthcare Private, Ltd.
FDA recalls by Wipro GE Healthcare Private, Ltd.
- 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
- 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
- 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.
- 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.
- Z-0961-2024 — GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
- 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
- Z-0958-2024 — GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
- 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
- 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
- Z-0962-2024 — GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Wipro GE Healthcare Private, Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.