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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95216

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Wipro GE Healthcare Private Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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-3080-2024
Recall number
Z-3080-2024
Initiated
August 09, 2024
Classification
Class II
Status
Ongoing
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Serial Number GBW24230381SA

Distribution pattern

US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.

device · product 2 of 2

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-3081-2024
Recall number
Z-3081-2024
Initiated
August 09, 2024
Classification
Class II
Status
Ongoing
Quantity
137 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

1) M1112198-01045518, UDI/DI 00840682152709, Serial Numbers: PBW23420278SA, PBW23390175SA, PBW24241071SA, PBW24241072SA, PBW24241075SA, PBW23340090SA; 2) M1112198-01045579, UDI/DI 00840682152709, Serial Numbers: PBW24241078SA, PBW24241079SA, PBW24241063SA, PBW24241076SA; 3) M1112198-01047148, UDI/DI 00840682152709, Serial Numbers: PBW24241068SA, PBW24241070SA, PBW24241065SA, PBW24241064SA, PBW24241066SA, PBW24241067SA, PBW24241069SA; 4) M1112198-01047271, UDI/DI 00840682152716, Serial Numbers: PBW23492144SA, PBW23482075SA, PBW23492149SA, PBW24062087SA, PBW24062078SA, PBW24062081SA, PBW23492145SA, PBW24152231SA, PBW24152225SA, PBW24152229SA, PBW23482085SA, PBW24202294SA, PBW24202292SA, PBW24202293SA, PBW24212323SA, PBW24212324SA, PBW24152226SA, PBW24152227SA, PBW24052060SA, PBW23492142SA; 5) M1112198-01048731, UDI/DI 00840682152709, Serial Numbers: PBW24241087SA, PBW24241086SA, PBW24241085SA, PBW23320042SA, PBW23320041SA, PBW24241084SA, PBW23320035SA; 6) M1112198-01048740, UDI/DI 00840682152716, Serial Numbers: PBW23482093SA; 7) M1112198-01052386, UDI/DI 00840682152716, Serial Numbers: PBW23482100SA, PBW24202309SA, PBW24202313SA, PBW24202310SA, PBW24202315SA, PBW24202312SA, PBW24202314SA, PBW24202311SA; 8) M1112198-01054697, UDI/DI 00840682152716, Serial Numbers: PBW24132200SA; 9) M1112198-01068942, UDI/DI 00840682152716, Serial Numbers: PBW23472056SA, PBW24062069SA, PBW24112144SA, PBW24062072SA, PBW24112157SA, PBW24112149SA, PBW24112145SA, PBW24112158SA, PBW24112148SA, PBW24112147SA, PBW24112155SA, PBW24112150SA, PBW24112153SA, PBW24112156SA, PBW24112152SA, PBW24112154SA, PBW24112146SA, PBW24112151SA, PBW24142209SA; 10) M1112198-01084972, UDI/DI 00840682152716, Serial Numbers: PBW23462025SA, PBW23462038SA, PBW23462039SA, PBW23472051SA, PBW23472049SA, PBW23472050SA, PBW24132204SA, PBW24132203SA, PBW24132205SA, PBW24122189SA, PBW24122190SA; 11) M1112198-01090848, UDI/DI 00840682152716, Serial Numbers: PBW24122198SA, PBW24122195SA, PBW24122197SA; 12) M1112198-01093457, UDI/DI 00840682152716, Serial Numbers: PBW24202308SA, PBW24132201SA; 13) M1112198-01117766, UDI/DI 00840682152709, Serial Numbers: PBW24110390SA; 14) M1112198-01139893, UDI/DI 00840682152716, Serial Numbers: PBW23242002SA, PBW23242003SA, PBW23242000SA, PBW23242001SA, PBW23512155SA, PBW24062070SA, PBW24172255SA, PBW24172253SA, PBW24172254SA, PBW24172251SA, PBW24172250SA, PBW24212327SA, PBW24212328SA; 15) M1112198-01156745, UDI/DI 00840682152716, Serial Numbers: PBW24192258SA; 16) M1112198-01167230, UDI/DI 00840682152716, Serial Numbers: PBW23462035SA, PBW23462036SA, PBW23462040SA, PBW24112159SA; 17) M1112198-01177090, UDI/DI 00840682152716, Serial Numbers: PBW23482099SA; 18) M1112198-01183599, UDI/DI 00840682152716, Serial Numbers: PBW23492140SA, PBW23482090SA, PBW23482092SA, PBW23482089SA, PBW23482086SA, PBW23492139SA, PBW23482087SA, PBW23482088SA, PBW23482091SA, PBW23482103SA, PBW23482104SA, PBW23482105SA; 19) M1112198-01185372, UDI/DI 00840682152716, Serial Numbers: PBW23482079SA, PBW23482081SA, PBW23482082SA, PBW23482083SA, PBW23482078SA; 20) M1112198-01193801, UDI/DI 00840682152716, Serial Numbers: PBW23502154SA, PBW24172252SA; 21) M1112198-01200764, UDI/DI 00840682152716, Serial Numbers: PBW23472043SA; 22) M1112198-01245548, UDI/DI 00840682152716, Serial Numbers: PBW24062101SA; 23) M1112198-01253742, UDI/DI 00840682152716, Serial Numbers: PBW24052062SA, PBW24052063SA, PBW24052066SA, PBW24052065SA, PBW24052064SA; 24) M1112198-01274059, UDI/DI 00840682152716, Serial Numbers: PBW24192278SA, PBW24192279SA.

Distribution pattern

US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.