🔍 RecallPedia

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Class I - Dangerous
🏥 Medical Devices Recalled: October 11, 2017 GE Medical Systems China Co. Other Medical Devices Nationwide

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  1. Check if you have this product:
    Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA SM717200075MA SM717200072MA SM717200073MA SM717200074MA SM617300054MA SM716390006MA SM716390007MA SM716390008MA SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717020023MA SM717020024MA SM717020025MA SM717200052MA SM716300041MA SM716300040MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM616400001MA SM716380022MA SM716380023MA SM716380024MA SM616250007MA SM616460048MA SM616460049MA SM617240035MA SM617240034MA SM617170052MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM616460022MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM717020030MA SM616250005MA SM616400004MA SM616400005MA 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems China Co., Ltd.
Reason for Recall:
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Product Codes/Lot Numbers:

Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA SM717200075MA SM717200072MA SM717200073MA SM717200074MA SM617300054MA SM716390006MA SM716390007MA SM716390008MA SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717020023MA SM717020024MA SM717020025MA SM717200052MA SM716300041MA SM716300040MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM616400001MA SM716380022MA SM716380023MA SM716380024MA SM616250007MA SM616460048MA SM616460049MA SM617240035MA SM617240034MA SM617170052MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM616460022MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM717020030MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM717200055MA SM717320026MA SM617310035MA SM617310032MA SM617310033MA SM617310034MA SM716510015MA SM716510016MA SM716510017MA SM717020040MA SM716300024MA SM716300025MA SM716300026MA SM716430052MA SM716430053MA SM716430054MA SM716430055MA SM717150063MA SM716480057MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617240031MA SM617240030MA SM717200058MA SM617340015MA SM617340013MA SM617340014MA SM617180039MA SM617180038MA SM617180042MA SM617180041MA SM617310038MA SM716480029MA SM716480030MA SM716480031MA SM716480032MA SM716480033MA SM616200020MA SM617310037MA SM617310036MA SM617310040MA SM617310039MA SM717150034MA SM717150033MA SM717150035MA SM717150036MA SM717150037MA SM717150038MA SM717150039MA SM717150047MA SM717150040MA SM717150041MA SM717150042MA SM717150043MA SM717150046MA SM717150044MA SM717150045MA SM717150048MA SM717150049MA SM717150050MA SM717150051MA SM717150052MA SM717150053MA SM717150054MA SM717150055MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM716270006MA SM716270007MA SM617010108MA SM616340023MA SM717010115MA SM717010117MA SM717010118MA SM717010120MA SM717010121MA SM717010122MA SM717010123MA SM717010124MA SM717010125MA SM717010126MA SM717010127MA SM717010128MA SM717010129MA SM717010130MA SM717010131MA SM717010132MA SM717010133MA SM717010134MA SM717010135MA SM717010136MA SM717010137MA SM717010138MA SM717010139MA SM717010140MA SM717020039MA SM717100035MA SM617180095MA SM616270021MA SM616270022MA SM717100043MA SM717100044MA SM717100045MA SM617020019MA SM617020020MA SM617020021MA SM717010116MA SM717010119MA SM616430024MA SM616460047MA SM716300027MA SM717320014MA SM717320012MA SM717320013MA SM716480058MA SM717100047MA SM717100048MA SM717100049MA SM716480055MA SM717100042MA SM716200046MA SM716200047MA SM616340001MA SM616340002MA SM616340039MA SM717010109MA SM717200051MA SM717200048MA SM717200049MA SM717200050MA SM716310001MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM716430066MA SM716430067MA SM716430068MA SM717200029MA SM717200026MA SM717200027MA SM717200028MA SM717200030MA SM617180102MA SM616250006MA SM717320009MA SM717320006MA SM717320007MA SM717320008MA SM717320010MA SM717320011MA SM717200098MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM817080012MA SM717200047MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM717200078MA SM616460030MA SM716390011MA SM716390012MA SM616460028MA SM616460029MA SM716270001MA SM617360027MA SM617360028MA SM717320044MA SM717320045MA SM717350023MA SM616410043MA SM717020047MA SM717020048MA SM717320027MA SM717150062MA SM717150061MA SM717010104MA SM716270008MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617140018MA SM617140015MA SM617140016MA SM617140017MA SM617260039MA SM617260038MA SM717200020MA SM617060084MA SM716250022MA SM716250023MA SM716430063MA SM716430064MA SM716430065MA SM617100056MA SM617100057MA SM616400016MA SM616400017MA SM717200085MA SM616170021MA SM616170022MA SM716300032MA SM716300033MA SM716300034MA SM716300035MA SM716300036MA SM716300037MA SM716300038MA SM716430047MA SM616200012MA SM617140033MA SM717100039MA SM717100040MA SM616340028MA SM616340029MA SM616340030MA SM716200048MA SM716200049MA SM716200050MA SM716250016MA SM716250017MA SM716250018MA SM717100056MA SM717200024MA SM717100041MA SM717100057MA SM716480056MA SM717020036MA SM716380017MA SM717200088MA SM717200086MA SM717200087MA SM717020057MA SM716380015MA SM717080055MA SM716480045MA SM716480046MA SM716480047MA SM716480048MA SM716480049MA SM716480050MA SM617100058MA SM716430050MA SM716430051MA SM716460006MA SM716460007MA SM617310008MA SM617310007MA SM617260040MA SM617260041MA SM617260042MA SM617260043MA SM617260044MA SM716300044MA SM716300045MA SM616340021MA SM716460023MA SM716460024MA SM716460025MA SM716460026MA SM716460027MA SM716460028MA SM716460029MA SM716460030MA SM716460031MA SM716460032MA SM716460033MA SM716460034MA SM716460035MA SM716460036MA SM716460037MA SM716460038MA SM716460039MA SM716460040MA SM716460041MA SM716460042MA SM716460063MA SM716460064MA SM716460065MA SM716460066MA SM716460067MA SM716460068MA SM716480034MA SM716480035MA SM716480036MA SM616430034MA SM616430035MA SM716300039MA SM717100046MA SM716460070MA SM617100157MA SM617140041MA SM717080060MA SM717150025MA SM717150024MA SM617100019MA SM617100020MA SM617100021MA SM617100022MA SM617100023MA SM617100024MA SM617100025MA SM617340021MA SM617340019MA SM617340020MA SM617180104MA SM617180103MA SM617260048MA SM617260047MA SM617170040MA SM617170039MA SM717200076MA SM616100020MA SM616100024MA SM616200015MA SM617020026MA SM716070006WA SM716100021MA SM716100022MA SM716100023MA SM716100025MA SM716100026MA SM716100027MA SM716100028MA SM716100029MA SM716100030MA SM716100031MA SM716100032MA SM716100033MA SM716100034MA SM716100035MA SM716200032MA SM716430033MA SM716430034MA SM716430046MA SM717010103MA SM716380018MA SM716380019MA SM716380020MA SM616100021MA SM616100022MA SM616100023MA SM616200013MA SM616200016MA SM716200033MA SM716200034MA SM716200035MA SM716200036MA SM716200037MA SM716200038MA SM716200039MA SM716200040MA SM716250019MA SM716250020MA SM716430031MA SM716430035MA SM717100034MA SM816350012MA SM716100024MA SM716200041MA SM716200042MA SM716200043MA SM716200044MA SM716430032MA SM617240026MA SM617240025MA SM716250021MA SM716300020MA SM716460010MA SM716460011MA SM716460012MA SM716460013MA SM716460014MA SM616200014MA SM717200094MA SM717200091MA SM717200092MA SM717200093MA SM717200095MA SM717200096MA SM717200097MA SM617020007MA SM617020008MA SM617020009MA SM616150007WA SM616220006WA SM616370002WA SM616370003WA SM616370006WA SM617040018WA SM617040019WA SM617040020WA SM617040021WA SM617040023WA SM617060002WA SM617120006WA SM617120007WA SM615500007WA SM617040022WA SM617060001WA SM617060004WA SM617300095WA 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SM816200001WA SM816200002WA SM816200003WA SM816200004WA SM816200005WA SM816270001WA SM816270002WA SM816380001WA SM816380002WA SM816380003WA SM817010001WA SM716070007WA SM717010142WA SM716460076WA SM716460077WA SM715470004WA SM715470005WA SM715470006WA SM715470007WA SM715470008WA SM715470009WA SM715470010WA SM715470011WA SM715470012WA SM715470013WA SM715470014WA SM715470015WA SM715470016WA SM715470017WA SM715470018WA SM715470019WA SM715280038WA SM716070012WA SM715500005WA SM715500006WA SM716040001WA SM716040002WA SM716040003WA SM716040004WA SM716260001WA SM716260002WA SM715500014WA SM716320019WA SM716320020WA SM716320021WA SM716320022WA SM717200112WA SM717200111WA SM717300014WA SM717300013WA SM716420028WA SM716420029WA SM716420030WA SM716420031WA SM716430001WA SM716430002WA SM716430003WA SM716430004WA SM716430005WA SM716430006WA SM716430007WA SM716430008WA SM716430009WA SM716430010WA SM716430011WA SM716430014WA SM716430015WA SM716430016WA SM716430017WA SM716430018WA SM716430019WA SM716430020WA SM716430021WA SM716430022WA SM716430023WA SM716430024WA SM716430025WA SM716440012WA SM716440013WA SM716440014WA SM716440015WA SM716440016WA SM716440017WA SM716440018WA SM715350073WA SM715350074WA SM716010010WA SM716300003WA SM716320002WA SM616340022MA SM616410056MA SM616410057MA SM616460031MA SM616460032MA SM616460033MA SM616460034MA SM716300023MA SM716460008MA SM716460009MA SM716460069MA SM716480037MA SM716480038MA SM716480039MA SM716480040MA SM716480041MA SM716480042MA SM716480043MA SM717080053MA SM717080054MA SM717100055MA SM616400014MA SM717200100MA SM717200099MA SM617160021WA SM717220002WA SM717360017WA SM616280032WA SM617110001WA SM617110002WA SM617110003WA SM715290045WA SM715420008WA SM715470021WA SM715470022WA SM715480001WA SM715480002WA SM715480010WA SM715480011WA SM715480012WA SM617190040WA SM617190037WA SM617190038WA SM617190039WA SM617300087WA SM617300003WA SM617300084WA SM617300086WA SM617350004WA SM617350002WA SM617350003WA SM717350090WA SM615370001WA SM616440025WA SM716100048WA SM716150011WA SM616300003WA SM616300004WA SM716010006WA SM716320008WA SM615350082WA SM615350083WA SM615350084WA SM615350085WA SM617210016WA SM617210015WA SM615370020WA SM615370021WA SM615370018WA SM615370019WA SM616430042WA SM616430044WA SM717080073WA SM717080074WA SM717080075WA SM717080076WA SM717210005WA SM615440001WA SM717090008WA SM615350088WA SM615350089WA SM716440005WA SM716510001WA SM717110015WA SM716440020WA SM616200002WA SM615440003WA SM616210001WA SM616210002WA SM616210003WA SM617020006WA SM617030011WA SM617040005WA SM617100069WA SM715450003WA SM717080070WA SM617210010WA SM617240021WA SM617270011WA SM717200019WA SM617140032MA SM617280006WA SM615510004WA SM615510005WA SM615510006WA SM616220020WA SM715490002WA SM617110009WA SM616220019WA SM616360005WA SM716300006WA SM615260034WA SM617040006WA SM717190007WA SM615370003WA SM715500018WA SM715500019WA SM715500020WA SM715500021WA SM715500022WA SM715510001WA SM715510002WA SM715510003WA SM715510004WA SM716240018WA SM716240019WA SM716360006WA SM615370022WA SM615500004WA SM615500009WA SM615510001WA SM615510002WA SM616190014WA SM616190016WA SM616220012WA SM616220013WA SM616360022WA SM616370001WA SM715260033WA SM715330049WA SM715480008WA SM716220002WA SM716420017WA SM717100065WA SM817100001WA SM817100002WA SM617190034WA SM617190033WA SM617200011WA SM617200010WA SM617230001WA SM617270010WA SM617280009WA SM617280007WA SM617280008WA SM617280010WA SM617360002WA SM617360001WA SM717230018WA SM717230015WA SM717230016WA SM717230017WA SM717230019WA SM717230020WA SM717230021WA SM717190008WA SM717210006WA SM717270019WA SM717270016WA SM717270017WA SM717270018WA SM717270020WA SM717280007WA SM717280005WA SM717280006WA SM717360009WA SM717320036MA SM617310003WA SM617310002WA SM616220001WA SM617070009WA SM617100014WA SM615510003WA SM616340044WA SM615370006WA SM615370008WA SM615370010WA SM615370011WA SM615370012WA SM717240024WA SM717240023WA SM615370005WA SM717360003WA SM717360001WA SM717360002WA SM617090008WA SM715510005WA SM715510006WA SM617210012WA SM616430043WA SM815460001WA SM815460002WA SM616220022WA SM716370009WA SM716360012WA SM717030001WA SM717240034WA SM717240033WA SM716330017WA SM617240015WA SM617240014WA SM615340070WA SM616240005WA SM616240006WA SM616320022WA SM715350076WA SM716230009WA SM616320023WA SM615370009WA SM716360008WA SM616220021WA SM616220025WA SM717080071WA SM717100003WA SM717100004WA SM716230010WA SM615430001WA SM615370007WA SM616220023WA SM616220024WA SM717060026WA SM615360005WA SM615440002WA SM616100038WA SM616150004WA SM616150005WA SM616150006WA SM61616000

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0579-2018

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