FDAFDA · Food and drugs·Recall number Z-2954-2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Published September 5, 2018 · Recall initiated: July 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Distributor
- Worldwide
- Lot
- (a) 620, A1: Serial Numbers: SM618060027MA SM618160055MA SM618160049MA SM618120029MA SM618120027MA SM618120026MA SM618120028MA SM618190086MA SM618190098MA SM618190095MA SM618190094MA SM618190093MA SM618190096MA SM618190097MA SM618060028MA SM618060025MA SM618060024MA SM618060023MA SM618060019MA SM618060015MA SM618060016MA SM618060017MA SM618130008WA SM618130010WA SM618130009WA SM618130007WA SM618130011WA SM618130012WA SM618200003WA SM618200002WA SM618200004WA SM618200005WA SM618120030MA SM618120031MA SM618120036MA SM618160011MA SM618160010MA SM618120032MA SM618120034MA SM618120033MA SM618120035MA SM618120037MA SM618100002WA SM618100003WA SM618100004WA SM618100001WA SM618100005WA SM618100006WA SM618100007WA SM618100008WA SM618100009WA SM618100010WA SM618100011WA SM618100012WA SM618160071MA SM618210084WA SM618070008WA SM618070009WA SM618070010WA SM618070007WA SM618070011WA SM618070006WA SM618200028WA SM618200027WA SM618150006WA SM618150007WA SM618150005WA SM618150003WA SM618150004WA SM618160092WA SM618080005WA SM618080003WA SM618080004WA SM618050010WA SM618050009WA SM618080006WA SM618210028WA SM618210026WA SM618210027WA SM618150018WA SM618150019WA SM618150008WA SM618150009WA SM618150010WA SM618150011WA SM618150012WA SM618150043WA SM618150044WA SM618150045WA SM618150042WA SM618150046WA SM618230034WA SM618230035WA SM618240002WA SM618230033WA SM618230036WA SM618230037WA SM618240003WA SM618240004WA SM618240005WA SM618240006WA SM618210020WA SM618210021WA SM618210018WA SM618210019WA SM618210022WA SM618210005WA SM618210006WA SM618210007WA SM618210004WA SM618210008WA SM618160094WA SM618160095WA SM618160093WA SM618160096WA SM618160097WA SM618160098WA SM618160099WA SM618160100WA SM618160101WA SM618150024WA SM618150025WA SM618150026WA SM618150023WA SM618150027WA SM618150028WA SM618150029WA SM618150030WA SM618150031WA SM618150032WA SM618070005WA SM618060002WA SM618150015WA SM618150016WA SM618150013WA SM618150014WA SM618150017WA SM618150020WA SM618150021WA SM618150022WA SM618060047MA SM618060049MA SM618060051MA SM618060043MA SM618060044MA SM618060046MA SM618060048MA SM618060050MA SM618060045MA SM618060052MA SM618190076MA SM618190078MA SM618190077MA SM618190082MA SM618190075MA SM618190079MA SM618190080MA SM618190081MA SM618160039MA SM618160043MA SM618160045MA SM618160040MA SM618160044MA SM618160042MA SM618160048MA SM618160046MA SM618160047MA SM618160041MA SM618160036MA SM618160035MA SM618160034MA SM618210056MA SM618210057MA SM618210064MA SM618190073MA SM618210067MA SM618190063MA SM618190068MA SM618190064MA SM618210070MA SM618210065MA SM618190069MA SM618190067MA SM618190065MA SM618210069MA SM618190066MA SM618210068MA SM618190070MA SM618210066MA SM618190072MA SM618190071MA SM618210071MA SM618190074MA SM618210032MA SM618210048MA SM618210030MA SM618210054MA SM618210055MA SM618210033MA SM618210029MA SM618210046MA SM618210042MA SM618210036MA SM618210039MA SM618210052MA SM618210031MA SM618210053MA SM618210049MA SM618210035MA SM618210038MA SM618210037MA SM618210043MA SM618210045MA SM618210047MA SM618210040MA SM618210034MA SM618210041MA SM618210051MA SM618210044MA SM618210050MA SM618230018WA SM618240013WA SM618170020WA SM618140010WA SM618190028WA SM618110012WA SM618160012MA SM618060006WA SM618230006WA SM618230016WA SM618230017WA SM618200014WA SM618200012WA SM618200013WA SM618200015WA SM618200020WA SM618200019WA SM618110004WA SM618080019WA SM618200017WA SM618200016WA SM618140006WA SM618140004WA SM618140005WA SM618110003WA SM618110005WA SM618110006WA SM618110001WA SM618110002WA SM618230005WA SM618200018WA SM618080018WA SM618060076WA SM618060008WA SM618060073WA SM618060074WA SM618060075WA SM618060077WA SM618060078WA SM618060064MA SM618060063MA SM618080001WA SM618150041WA SM618190026WA SM618200
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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