| | Class 1 Device Recall GE Healthcare Incubator Carestation CS1 |  |
| Date Initiated by Firm | June 06, 2023 |
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| Date Posted | October 31, 2024 |
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| Recall Status1 |
Completed |
| Recall Number | Z-0141-2025 |
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| Recall Event ID |
95456 |
| 510(K)Number | K152809 K213553 |
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| Product Classification |
Incubator, neonatal - Product Code FMZ
|
| Product | GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:
1) 2082844-002-01040417;
2) 2082844-002-01044956;
3) 2082844-002-01058424;
4) 2082844-002-01069017;
5) 2082844-002-01089666;
6) 2082844-002-01090474;
7) 2082844-002-01091269;
8) 2082844-002-01093489;
9) 2082844-002-01113262;
10) 2082844-002-01113711;
11) 2082844-002-01123085;
12) 2082844-002-01123918;
13) 2082844-002-01128966;
14) 2082844-002-01133042;
15) 2082844-002-01146447;
16) 2082844-002-100205;
17) 2082844-002-100749;
18) 2082844-002-100752;
19) 2082844-002-100995;
20) 2082844-002-101425;
21) 2082844-002-523548;
22) 2082844-002-529928;
23) 2082844-002-594800;
24) 2082844-002-643544;
25) 2082844-002-925841;
26) 2082844-002-965540;
27) 2082844-002-982916;
28) 2082844-002-983420;
29) 2082844-002-993905;
30) 2082844-002-995018;
31) 2082844-002-995799;
32) 2082844-002-998943; Radiant infant warmer |
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| Code Information |
1) 2082844-002-01040417, UDI: (01)00840682116855(21)TAAC70003(11)230106, (01)00840682116855(21)TAAC70004(11)230109, (01)00840682116855(21)TAAC70011(11)230110, (01)00840682116855(21)TAAC70012(11)230110, (01)00840682116855(21)TAAC70013(11)230111, (01)00840682116855(21)TAAC70015(11)230112, (01)00840682116855(21)TAAC70016(11)230112, (01)00840682116855(21)TAAC70020(11)230112, (01)00840682116855(21)TAAC70022(11)230112, (01)00840682116855(21)TAAC70024(11)230112, (01)00840682116855(21)TAAC70147(11)230317, (01)00840682116855(21)TAAC70148(11)230317, (01)00840682116855(21)TAAC70149(11)230317, (01)00840682116855(21)TAAC70150(11)230317, (01)00840682116855(21)TAAC70152(11)230320, (01)00840682116855(21)TAAC70153(11)230320, (01)00840682116855(21)TAAC70155(11)230322, (01)00840682116855(21)TAAC70158(11)230322, (01)00840682116855(21)TAAC70159(11)230323, (01)00840682116855(21)TAAC70160(11)230323, (01)00840682116855(21)TAAC70161(11)230323, (01)00840682116855(21)TAAC70162(11)230323, (01)00840682116855(21)TAAC70163(11)230324, (01)00840682116855(21)TAAC70164(11)230324, (01)00840682116855(21)TAAC70165(11)230324, (01)00840682116855(21)TAAC70166(11)230324, (01)00840682116855(21)TAAC70167(11)230327, (01)00840682116855(21)TAAC70169(11)230327, (01)00840682116855(21)TAAC70170(11)230327, (01)00840682116855(21)TAAC70171(11)230328, (01)00840682116855(21)TAAC70177(11)230330, (01)00840682116855(21)TAAC70178(11)230330, (01)00840682116855(21)TAAC70179(11)230331, (01)00840682116855(21)TAAC70181(11)230331, (01)00840682116855(21)TAAC70182(11)230331, (01)00840682116855(21)TAAC70184(11)230331, (01)00840682116855(21)TAAC70192(11)230405, (01)00840682116855(21)TAAC70193(11)230405, (01)00840682116855(21)TAAC70196(11)230405, (01)00840682116855(21)TAAC70197(11)230405, (01)00840682116855(21)TAAC70200(11)230407, (01)00840682116855(21)TAAC70201(11)230407, (01)00840682116855(21)TAAC70202(11)230407, (01)00840682116855(21)TAAC70203(11)230407, (01)00840682116855(21)TAAC70204(11)230407, (01)00840682116855(21)TAAC70205(11)230407, (01)00840682116855(21)TAAC70208(11)230411, (01)00840682116855(21)TAAC70209(11)230411, (01)00840682116855(21)TAAC70210(11)230411, (01)00840682116855(21)TAAC70211(11)230414, (01)00840682116855(21)TAAC70212(11)230414, (01)00840682116855(21)TAAC70213(11)230414, (01)00840682116855(21)TAAC70214(11)230414, (01)00840682116855(21)TAAC70215(11)230417, (01)00840682116855(21)TAAC70216(11)230417, (01)00840682116855(21)TAAC70217(11)230417, (01)00840682116855(21)TAAC70218(11)230417, (01)00840682116855(21)TAAC70223(11)230418, (01)00840682116855(21)TAAC70224(11)230418, (01)00840682116855(21)TAAC70225(11)230418, (01)00840682116855(21)TAAC70226(11)230418, (01)00840682116855(21)TAAC70227(11)230418, (01)00840682116855(21)TAAC70228(11)230418, (01)00840682116855(21)TAAC70229(11)230419, (01)00840682116855(21)TAAC70242(11)230421, (01)00840682116855(21)TAAC70243(11)230421, (01)00840682116855(21)TAAC70244(11)230421, (01)00840682116855(21)TAAC70245(11)230421, (01)00840682116855(21)TAAC70246(11)230421, (01)00840682116855(21)TAAC70247(11)230421;
2) 2082844-002-01044956, UDI: (01)008406821168552(21)TAA23140007SA(11)230404, (01)008406821168552(21)TAA23140008SA(11)230404;
3) 2082844-002-01058424, UDI: (01)00840682116855(21)TAAC70142(11)230213;
4) 2082844-002-01069017, UDI: (01)008406821168552(21)TAA23110001SA(11)230316, (01)008406821168552(21)TAA23110002SA(11)230316, (01)008406821168552(21)TAA23110003SA(11)230316;
5) 2082844-002-01089666, UDI: (01)00840682116855(21)TAAC70124(11)230201;
6) 2082844-002-01090474, UDI: (01)00840682116855(21)TAAC70126(11)230201, (01)00840682116855(21)TAAC70128(11)230206, (01)00840682116862(21)TAAC70132(11)230206, (01)00840682116855(21)TAAC70133(11)230206, (01)00840682116855(21)TAAC70125(11)230201, (01)00840682116855(21)TAAC70127(11)230206, (01)00840682116855(21)TAAC70129(11)230206, (01)00840682116855(21)TAAC70131(11)230206, (01)00840682116855(21)TAAC70136(11)230206, (01)00840682116855(21)TAAC70137(11)230206;
7) 2082844-002-01091269, UDI: (01)008406821168552(21)TAA23090001SA(11)230228
228;
8) 2082844-002-01093489, UDI: (01)00840682116855(21)TAAC70187(11)230403, (01)00840682116855(21)TAAC70188(11)230403, (01)00840682116855(21)TAAC70189(11)230403, (01)00840682116855(21)TAAC70190(11)230403, (01)00840682116855(21)TAAC70191(11)230403;
9) 2082844-002-01113262, UDI: (01)008406821168552(21)TAA23050010SA(11)230130, (01)008406821168552(21)TAA23050011SA(11)230130, (01)008406821168552(21)TAA23050012SA(11)230130, (01)008406821168552(21)TAA23050013SA(11)230130;
10) 2082844-002-01113711, UDI: (01)008406821168552(21)TAA23130005SA(11)230328, (01)008406821168552(21)TAA23130007SA(11)230329, (01)008406821168552(21)TAA23130008SA(11)230329, (01)008406821168552(21)TAA23130009SA(11)230329;
11) 2082844-002-01123085, UDI: (01)008406821168552(21)TAA23190005SA(11)230513, (01)008406821168552(21)TAA23190006SA(11)230513, (01)008406821168552(21)TAA23190007SA(11)230513, (01)008406821168552(21)TAA23190008SA(11)230513, (01)008406821168552(21)TAA23190009SA(11)230513, (01)008406821168552(21)TAA23190010SA(11)230513;
12) 2082844-002-01123918, UDI: (01)008406821168552(21)TAA23130001SA(11)230328;
13) 2082844-002-01128966, UDI: (01)008406821168552(21)TAA23040022SA(11)230127;
14) 2082844-002-01133042, UDI: (01)008406821168552(21)TAA23130003SA(11)230328, (01)008406821168552(21)TAA23130004SA(11)230328, (01)008406821168552(21)TAA23130006SA(11)230329;
15) 2082844-002-01146447, UDI: (01)008406821168552(21)TAA23100001SA(11)230307;
16) 2082844-002-100205, UDI: (01)008406821168552(21)TAA23030030SA(11)230121;
17) 2082844-002-100749, UDI: (01)00840682116855(21)TAAC70272(11)230426;
18) 2082844-002-100752, UDI: (01)00840682116855(21)TAAC70075(11)230123, (01)00840682116855(21)TAAC70083(11)230124, (01)00840682116855(21)TAAC70084(11)230124, (01)00840682116855(21)TAAC70086(11)230125, (01)00840682116855(21)TAAC70087(11)230125;
19) 2082844-002-100995, UDI: (01)008406821168552(21)TAA23090003SA(11)230228, (01)008406821168552(21)TAA23090004SA(11)230228, (01)008406821168552(21)TAA23090005SA(11)230228, (01)008406821168552(21)TAA23090006SA(11)230228, (01)008406821168552(21)TAA23090002SA(11)230228, (01)008406821168552(21)TAA23090007SA(11)230228;
20) 2082844-002-101425, UDI: (01)008406821168552(21)TAA23190003SA(11)230512, (01)008406821168552(21)TAA23160001SA(11)230419, (01)008406821168552(21)TAA23170001SA(11)230424, (01)008406821168552(21)TAA23130031SA(11)230331, (01)008406821168552(21)TAA23130032SA(11)230331, (01)008406821168552(21)TAA23130033SA(11)230331, (01)008406821168552(21)TAA23130034SA(11)230331, (01)008406821168552(21)TAA23130035SA(11)230331, (01)008406821168552(21)TAA23130036SA(11)230331, (01)008406821168552(21)TAA23130021SA(11)230330, (01)00840682116855(21)TAAC70143(11)230224, (01)00840682116855(21)TAAC70144(11)230224, (01)00840682116855(21)TAAC70145(11)230224, (01)008406821168552(21)TAA23130025SA(11)230331, (01)008406821168552(21)TAA23130026SA(11)230331, (01)008406821168552(21)TAA23130027SA(11)230331, (01)008406821168552(21)TAA23130028SA(11)230331, (01)008406821168552(21)TAA23130029SA(11)230331, (01)008406821168552(21)TAA23130030SA(11)230331, (01)00840682116855(21)TAAC70146(11)230313, (01)008406821168552(21)TAA23140001SA(11)230403, (01)008406821168552(21)TAA23140002SA(11)230403, (01)008406821168552(21)TAA23130022SA(11)230330, (01)008406821168552(21)TAA23130023SA(11)230330, (01)008406821168552(21)TAA23130024SA(11)230330, (01)008406821168552(21)TAA23160002SA(11)230419;
21) 2082844-002-523548, UDI: (01)00840682116855(21)TAAW62043(11)170130; (01)00840682116855(21)TAAZ70271(11)200224;
22) 2082844-002-529928, UDI: (01)008406821168552(21)TAA23130002SA(11)230328;
23) 2082844-002-594800, UDI: (01)00840682116855(21)TAAB70352(11)220520;
24) 2082844-002-643544, UDI: (01)008406821168552(21)TAA23030023SA(11)230120, (01)008406821168552(21)TAA23030024SA(11)230120, (01)008406821168552(21)TAA23030025SA(11)230120;
25) 2082844-002-925841, UDI: (01)00840682116855(21)TAAB70547(11)220815;
26) 2082844-002-965540, UDI: (01)00840682116855(21)TAAB70617(11)220826, (01)00840682116855(21)TAAB70665(11)220928, (01)00840682116855(21)TAAB70666(11)220928, (01)00840682116855(21)TAAB70670(11)220929, (01)00840682116855(21)TAAB70671(11)220929, (01)00840682116855(21)TAAB70681(11)221003, (01)00840682116855(21)TAAB70691(11)221004, (01)00840682116855(21)TAAB70702(11)221005, (01)00840682116855(21)TAAB70703(11)221005, (01)00840682116855(21)TAAB70732(11)221010;
27) 2082844-002-982916, UDI: (01)00840682116855(21)TAAC70033(11)230113, (01)00840682116855(21)TAAC70037(11)230116, (01)00840682116855(21)TAAC70044(11)230116, (01)00840682116855(21)TAAC70052(11)230119, (01)00840682116855(21)TAAC70058(11)230119, (01)00840682116855(21)TAAC70059(11)230119, (01)00840682116855(21)TAAC70060(11)230119, (01)00840682116855(21)TAAC70065(11)230120, (01)00840682116855(21)TAAC70067(11)230123, (01)00840682116855(21)TAAC70068(11)230123, (01)00840682116855(21)TAAB70608(11)220824;
28) 2082844-002-983420, UDI: (01)00840682116855(21)TAAC70076(11)230123, (01)00840682116855(21)TAAC70078(11)230124, (01)00840682116855(21)TAAC70079(11)230124, (01)00840682116855(21)TAAC70082(11)230124, (01)00840682116855(21)TAAC70089(11)230125, (01)00840682116855(21)TAAC70090(11)230125, (01)00840682116855(21)TAAC70092(11)230126, (01)00840682116855(21)TAAC70093(11)230126;
29) 2082844-002-993905, UDI: (01)008406821168552(21)TAA23040004SA(11)230123, (01)008406821168552(21)TAA23040005SA(11)230123, (01)008406821168552(21)TAA23040006SA(11)230124, (01)008406821168552(21)TAA23050014SA(11)230130;
30) 2082844-002-995018, UDI: (01)00840682116855(21)TAAB70551(11)220815, (01)00840682116855(21)TAAB70558(11)220819;
31) 2082844-002-995799, UDI: (01)008406821168552(21)TAA23040019SA(11)230127, (01)008406821168552(21)TAA23040020SA(11)230127, (01)008406821168552(21)TAA23190004SA(11)230513, (01)008406821168552(21)TAA23160007SA(11)230420, (01)008406821168552(21)TAA23160009SA(11)230420, (01)008406821168552(21)TAA23130015SA(11)230329, (01)008406821168552(21)TAA23130016SA(11)230329, (01)008406821168552(21)TAA23130017SA(11)230329, (01)008406821168552(21)TAA23130018SA(11)230329, (01)008406821168552(21)TAA23130020SA(11)230329, (01)008406821168552(21)TAA23160003SA(11)230419, (01)008406821168552(21)TAA23160004SA(11)230419, (01)008406821168552(21)TAA23160005SA(11)230419, (01)008406821168552(21)TAA23160006SA(11)230419, (01)008406821168552(21)TAA23160008SA(11)230420, (01)008406821168552(21)TAA23160010SA(11)230420, (01)008406821168552(21)TAA23160011SA(11)230420, (01)008406821168552(21)TAA23200003SA(11)230515, (01)008406821168552(21)TAA23200004SA(11)230515, (01)008406821168552(21)TAA23200005SA(11)230515, (01)008406821168552(21)TAA23200006SA(11)230515, (01)008406821168552(21)TAA23200007SA(11)230515, (01)008406821168552(21)TAA23200008SA(11)230515, (01)008406821168552(21)TAA23200009SA(11)230515, (01)008406821168552(21)TAA23200010SA(11)230515, (01)008406821168552(21)TAA23130019SA(11)230329;
32) 2082844-002-998943, UDI: (01)00840682116855(21)TAAC70050(11)230119, (01)00840682116855(21)TAAC70053(11)230119, (01)00840682116855(21)TAAC70110(11)230130
|
Recalling Firm/
Manufacturer |
DATEX--OHMEDA, INC.
9900 W Innovation Dr
Wauwatosa WI 53226-4856
|
| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer Reason
for Recall | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | GE HealthCare notified its consignees of the issue by letter beginning on 06/06/2023 using a traceable means. The notice explained the issue of potentially higher levels of formaldehyde which rapidly decrease of a week, and instructions on how to accelerate the rate of dissipation if the unit had not yet been put into clinical use.
For questions: contact 1-800-437-1171 or your local GE HealthCare Representative |
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| Quantity in Commerce | 224 units |
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| Distribution | worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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| 510(K) Database | 510(K)s with Product Code = FMZ
510(K)s with Product Code = FMZ
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