FDA · Medical device recall

Carestation 620/650/650c A1 Product Usage: anesthesia systems are… and 1 more product

Jan. 29, 2020 Class I

Date: Jan. 29, 2020
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.

2 products in this recall

Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation…

Product: Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Quantity: 3319 units
Codes and lots: CARESTATION 620 A1, Model Number 1012-9620-000 Mfg. Lot or Serial # UDI # SM619130003MA 010084068210398521SM619130003MA11190326 SM619120026MA 010084068210398521SM619120026MA11190321 SM619030025MA 010084068210398521SM619030025MA11190117 SM619020017MA 010084068210398521SM619020017MA11190108 SM619020018MA 010084068210398521SM619020018MA11190108 SM619180019MA 010084068210398521SM619180019MA11190502 SM619020063MA 010084068210398521SM619020063MA11190111 SM619020064MA 010084068210398521SM619020064MA11190111 SM619020065MA 010084068210398521SM619020065MA11190111 SM619110001MA 010084068210398521SM619110001MA11190311 SM618380015MA 010084068210398521SM618380015MA11180918 SM619060074MA 010084068210398521SM619060074MA11190208 SM618460073MA 010084068210398521SM618460073MA11181116 SM619170031MA 010084068210398521SM619170031MA11190422 SM619170032MA 010084068210398521SM619170032MA11190422 SM619170033MA 010084068210398521SM619170033MA11190422 SM618440026MA 010084068210398521SM618440026MA11181101 SM619020021MA 010084068210398521SM619020021MA11190110 SM619020022MA 010084068210398521SM619020022MA11190110 SM619140004MA 010084068210398521SM619140004MA11190402 SM618440027MA 010084068210398521SM618440027MA11181101 SM618440028MA 010084068210398521SM618440028MA11181101 SM619020014MA 010084068210398521SM619020014MA11190108 SM619020015MA 010084068210398521SM619020015MA11190108 SM619020016MA 010084068210398521SM619020016MA11190108 SM618500025MA 010084068210398521SM618500025MA11181214 SM618500026MA 010084068210398521SM618500026MA11181214 SM618500027MA 010084068210398521SM618500027MA11181214 SM619070010MA 010084068210398521SM619070010MA11190211 SM618470011MA 010084068210398521SM618470011MA11181120 SM618470012MA 010084068210398521SM618470012MA11181120 SM618400007MA 010084068210398521SM618400007MA11181004 SM618400008MA 010084068210398521SM618400008MA11181004 SM619090008MA 010084068210398521SM619090008MA11190225 SM619090009MA 010084068210398521SM619090009MA11190225 SM619230002MA 010084068210398521SM619230002MA11190603 SM618380016MA 010084068210398521SM618380016MA11180918 SM618430002MA 010084068210398521SM618430002MA11181022 SM618380041MA 010084068210398521SM618380041MA11180921 SM618380042MA 010084068210398521SM618380042MA11180921 SM618500024MA 010084068210398521SM618500024MA11181214 SM619140031MA 010084068210398521SM619140031MA11190405 SM619140032MA 010084068210398521SM619140032MA11190405 SM619140033MA 010084068210398521SM619140033MA11190405 SM619140034MA 010084068210398521SM619140034MA11190405 SM619140035MA 010084068210398521SM619140035MA11190405 SM618440033MA 010084068210398521SM618440033MA11181101 SM618490022MA 010084068210398521SM618490022MA11181206 SM618490023MA 010084068210398521SM618490023MA11181206 SM619030026MA 010084068210398521SM619030026MA11190117 SM619180005MA 010084068210398521SM619180005MA11190429 SM619180006MA 010084068210398521SM619180006MA11190429 SM619180007MA 010084068210398521SM619180007MA11190429 SM619180008MA 010084068210398521SM619180008MA11190429 SM618500006MA 010084068210398521SM618500006MA11181212 SM618500007MA 010084068210398521SM618500007MA11181212 SM618500008MA 010084068210398521SM618500008MA11181212 SM618500009MA 010084068210398521SM618500009MA11181212 SM618500010MA 010084068210398521SM618500010MA11181212 SM619070011MA 010084068210398521SM619070011MA11190211 SM619070012MA 010084068210398521SM619070012MA11190211 SM619070013MA 010084068210398521SM619070013MA11190211 SM619070014MA 010084068210398521SM619070014MA11190211 SM618430015MA 010084068210398521SM618430015MA11181025 SM618390017MA 010084068210398521SM618390017MA11180926 SM618390018MA 010084068210398521SM618390018MA11180926 SM618390019MA 010084068210398521SM618390019MA11180926 SM618390020MA 010084068210398521SM618390020MA11180926 SM619130009MA 010084068210398521SM619130009MA11190329 SM619130010MA 010084068210398521SM619130010MA11190329 SM619130011MA 010084068210398521SM619130011MA11190329 SM619130012MA 010084068210398521SM619130012MA11190329 SM619100010MA 010084068210398521SM619100010MA11190305 SM619190036MA 010084068210398521SM619190036MA11190508 SM618440029MA 010084068210398521SM618440029MA11181101 SM618440030MA 010084068210398521SM618440030MA11181101 SM618440032MA 010084068210398521SM618440032MA11181101 SM619050021MA 010084068210398521SM619050021MA11190201 SM619060029MA 010084068210398521SM619060029MA11190206 SM618500012MA 010084068210398521SM618500012MA11181213 SM618500013MA 010084068210398521SM618500013MA11181213 SM619040003MA 010084068210398521SM619040003MA11190122 SM619040004MA 010084068210398521SM619040004MA11190122 SM619060068MA 010084068210398521SM619060068MA11190206 SM619080001MA 010084068210398521SM619080001MA11190218 SM619050004MA 010084068210398521SM619050004MA11190129 SM619050005MA 010084068210398521SM619050005MA11190129 SM619050006MA 010084068210398521SM619050006MA11190129 SM619050007MA 010084068210398521SM619050007MA11190129 SM619050008MA 010084068210398521SM619050008MA11190129 SM619050009MA 010084068210398521SM619050009MA11190129 SM619050010MA 010084068210398521SM619050010MA11190129 SM618440031MA 010084068210398521SM618440031MA11181101 SM619160017MA 010084068210398521SM619160017MA11190418 SM619170083MA 010084068210398521SM619170083MA11190426 SM619170084MA 010084068210398521SM619170084MA11190426 SM619170085MA 010084068210398521SM619170085MA11190426 SM619140024MA 010084068210398521SM619140024MA11190403 SM619140025MA 010084068210398521SM619140025MA11190403 SM619210014MA 010084068210398521SM619210014MA11190522 SM619230012MA 010084068210398521SM619230012MA11190605 SM619060075MA 010084068210398521SM619060075MA11190208 SM619060076MA 010084068210398521SM619060076MA11190208 SM619060077MA 010084068210398521SM619060077MA11190208 SM619060078MA 010084068210398521SM619060078MA11190208 SM618440025MA 010084068210398521SM618440025MA11181101 SM619060073MA 010084068210398521SM619060073MA11190208 SM619140005MA 010084068210398521SM619140005MA11190402 SM619050012MA 010084068210398521SM619050012MA11190131 SM619050013MA 010084068210398521SM619050013MA11190131 SM619050014MA 010084068210398521SM619050014MA11190131 SM619050015MA 010084068210398521SM619050015MA11190131 SM619050016MA 010084068210398521SM619050016MA11190131 SM619270005MA 010084068210398521SM619270005MA11190702 SM619180011MA 010084068210398521SM619180011MA11190429 SM619180012MA 010084068210398521SM619180012MA11190429 SM619220059MA 010084068210398521SM619220059MA11190530 SM619030027MA 010084068210398521SM619030027MA11190117 SM618380043MA 010084068210398521SM618380043MA11180921 SM619030008MA 010084068210398521SM619030008MA11190114 SM619030009MA 010084068210398521SM619030009MA11190114 SM618430023MA 010084068210398521SM618430023MA11181026 SM618440024MA 010084068210398521SM618440024MA11181101 SM619180017MA 010084068210398521SM619180017MA11190501 SM619180018MA 010084068210398521SM619180018MA11190501 SM619030028MA 010084068210398521SM619030028MA11190117 SM619030024MA 010084068210398521SM619030024MA11190117 SM619180009MA 010084068210398521SM619180009MA11190429 SM619180010MA 010084068210398521SM619180010MA11190429 SM618410023WA 010084068210398521SM618410023WA11181011 SM618410024WA 010084068210398521SM618410024WA11181011 SM618410025WA 010084068210398521SM618410025WA11181011 SM618410026WA 010084068210398521SM618410026WA11181011 SM618410027WA 010084068210398521SM618410027WA11181011 SM618460043WA 010084068210398521SM618460043WA11181114 SM618420013WA 010084068210398521SM618420013WA11181016 SM618420016WA 010084068210398521SM618420016WA11181016 SM618420017WA 010084068210398521SM618420017WA11181016 SM619070023WA 010084068210398521SM619070023WA11190212 SM618420007WA 010084068210398521SM618420007WA11181016 SM618420010WA 010084068210398521SM618420010WA11181016 SM618420012WA 010084068210398521SM618420012WA11181016 SM618420015WA 010084068210398521SM618420015WA11181016 SM618420018WA 010084068210398521SM618420018WA11181016 SM618420008WA 010084068210398521SM618420008WA11181016 SM618420019WA 010084068210398521SM618420019WA11181016 SM618460046WA 010084068210398521SM618460046WA11181114 SM619070024WA 010084068210398521SM619070024WA11190212 SM619150034WA 010084068210398521SM619150034WA11190411 SM618460041WA 010084068210398521SM618460041WA11181114 SM618460042WA 010084068210398521SM618460042WA11181114 SM618460044WA 010084068210398521SM618460044WA11181114 SM619070021WA 010084068210398521SM619070021WA11190212 SM619070026WA 010084068210398521SM619070026WA11190212 SM618420006WA 010084068210398521SM618420006WA11181016 SM618420014WA 010084068210398521SM618420014WA11181016 SM618460045WA 010084068210398521SM618460045WA11181114 SM618460047WA 010084068210398521SM618460047WA11181114 SM619070022WA 010084068210398521SM619070022WA11190212 SM619070033WA 010084068210398521SM619070033WA11190214 SM619070019WA 010084068210398521SM619070019WA11190212 SM619070025WA 010084068210398521SM619070025WA11190212 SM619070027WA 010084068210398521SM619070027WA11190212 SM619070034WA 010084068210398521SM619070034WA11190214 SM618420004WA 010084068210398521SM618420004WA11181015 SM618420009WA 010084068210398521SM618420009WA11181016 SM618420011WA 010084068210398521SM618420011WA11181016 SM618460040WA 010084068210398521SM618460040WA11181114 SM618460054MA 010084068210398521SM618460054MA11181114 SM618460055MA 010084068210398521SM618460055MA11181114 SM618460056MA 010084068210398521SM618460056MA11181114 SM619080013MA 010084068210398521SM619080013MA11190220 SM619080014MA 010084068210398521SM619080014MA11190220 SM619080015MA 010084068210398521SM619080015MA11190220 SM619080016MA 010084068210398521SM619080016MA11190220 SM619080017MA 010084068210398521SM619080017MA11190220 SM619080023MA 010084068210398521SM619080023MA11190221 SM619080024MA 010084068210398521SM619080024MA11190221 SM619250014MA 010084068210398521SM619250014MA11190618 SM619250015MA 010084068210398521SM619250015MA11190618 SM619050001WA 010084068210398521SM619050001WA11190128 SM618450018WA 010084068210398521SM618450018WA11181107 SM619120005WA 010084068210398521SM619120005WA11190318 SM619120006WA 010084068210398521SM619120006WA11190318 SM619120007WA 010084068210398521SM619120007WA11190318 SM619020010WA 010084068210398521SM619020010WA11190108 SM619020012WA 010084068210398521SM619020012WA11190108 SM619020009WA 010084068210398521SM619020009WA11190108 SM619020011WA 010084068210398521SM619020011WA11190108 SM618440001WA 010084068210398521SM618440001WA11181029 SM618440002WA 010084068210398521SM618440002WA11181029 SM618440003WA 010084068210398521SM618440003WA11181029 SM619050020WA 010084068210398521SM619050020WA11190201 SM618460069WA 010084068210398521SM618460069WA11181116 SM619060080MA 010084068210398521SM619060080MA11190208 SM619060081MA 010084068210398521SM619060081MA11190208 SM619270012MA 010084068210398521SM619270012MA11190703 SM619270018MA 010084068210398521SM619270018MA11190703 SM619270033MA 010084068210398521SM619270033MA11190703 SM619270034MA 010084068210398521SM619270034MA11190703 SM619270035MA 010084068210398521SM619270035MA11190703 SM619270036MA 010084068210398521SM619270036MA11190703 SM619270037MA 010084068210398521SM619270037MA11190703 SM619270038MA 010084068210398521SM619270038MA11190703 SM619270039MA 010084068210398521SM619270039MA11190703 SM619270040MA 010084068210398521SM619270040MA11190703 SM619270041MA 010084068210398521SM619270041MA11190703 SM619270043MA 010084068210398521SM619270043MA11190703 SM619270050MA 010084068210398521SM619270050MA11190703 SM618360071WA 010084068210398521SM618360071WA11180908 SM619270044MA 010084068210398521SM619270044MA11190703 SM619270045MA 010084068210398521SM619270045MA11190703 SM618360068WA 010084068210398521SM618360068WA11180908 SM618360064WA 010084068210398521SM618360064WA11180908 SM618360061WA 010084068210398521SM618360061WA11180908 SM618360070WA 010084068210398521SM618360070WA11180908 SM619190047WA 010084068210398521SM619190047WA11190510 SM619190048WA 010084068210398521SM619190048WA11190510 SM619200001WA 010084068210398521SM619200001WA11190513 SM619200002WA 010084068210398521SM619200002WA11190513 SM619200003WA…
Recall started: Nov. 25, 2019
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: The firm initiated their field notification by letter on November 25, 2019. The letter states the reason for recall and provides the following safety instructions: You can continue to use the anesthesia system. - If you observe the message Ventilate Manually! , change from mechanical to manual ventilation. At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device. Contact your GE Healthcare representative for repair of the device. - Perform the planned maintenance (PM) every 12-months at a minimum per the User s Reference Manual which includes inspection of the cable connection. Note: This inspection step is included in the annual PM described in the Technical Reference Manual. Performing this step in the PM would confirm the integrity of the cable connection. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm will be correcting the units. The firm issued a Press Release on January 13, 2020.
Recall number: Z-0813-2020

Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation…

Product: Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Quantity: 280 units
Codes and lots: CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA SM618370005WA SM618370006WA SM618370010WA SM618370070WA SM618370071WA SM618380001WA SM618380002WA SM618380008WA SM618380009WA SM618380010WA SM618380011WA SM618450033WA SM618480061WA SM618500014WA SM619110035WA SM618360022WA SM618360027WA SM618360028WA SM618370020WA SM618370021WA SM618370022WA SM618370023WA SM618370051WA SM618370052WA SM618370053WA SM618370056WA SM618360007WA SM619030013WA SM619030014WA SM619030015WA SM619030016WA SM619040001WA SM619150001WA SM618430007WA SM618440004WA SM618480064WA SM618390031WA SM619100010WA SM618420021WA SM618420022WA SM618420023WA SM618420024WA SM618480063WA SM619070003WA SM619170051WA SM618460048WA SM619070001WA SM619070002WA SM618410001WA SM618410002WA SM618500015WA SM618450034WA SM618380007WA SM619030007WA SM619110044WA SM619120001WA SM619135003WA SM618440035WA SM619110011WA SM618360011WA SM618450013WA SM619090011WA SM618460062WA SM618350016WA SM618460049WA SM618460050WA SM618460051WA SM618480036WA SM618380017WA SM618380018WA SM618500004WA SM618500005WA SM618430008WA SM618450012WA SM618490017WA SM618490018WA SM619030012WA SM619135004WA SM618380014WA SM618370073WA SM619120002WA SM619120003WA SM619120004WA SM618430005WA SM618490010WA SM618490013WA SM618490014WA SM618380020WA SM618500001WA SM618500002WA SM618360009WA SM618360013WA SM618370024WA SM618500016WA SM618500017WA SM618500018WA SM618500019WA SM618500020WA SM618500021WA SM618380003WA SM618380004WA SM618370072WA SM618370074WA SM618490015WA SM618490016WA SM618490019WA SM618490020WA SM618490025WA SM618490026WA SM618500003WA SM618370014WA SM618370015WA SM618370016WA SM618370017WA SM618370018WA SM618370019WA SM618370013WA SM619080002WA SM618420020WA SM619080022WA SM618510004WA SM618510005WA SM618510006WA SM619020020WA SM619090008WA SM619090009WA SM619090010WA SM619090012WA SM619090013WA SM618370054WA SM618390009WA SM618390010WA SM619110002WA SM619110003WA SM619110004WA SM619110006WA SM619110007WA SM619110009WA SM619110012WA SM619110014WA SM619230009WA SM619110005WA SM619110008WA SM619110013WA SM619110015WA SM619110021WA SM619110022WA SM619110023WA SM619200048WA SM619200049WA SM619210001WA SM619210002WA SM618340078WA SM619110024WA SM619040006WA SM618370068WA SM618370069WA SM619110018WA SM619110019WA SM619110020WA SM619170001WA SM619110016WA SM619110017WA SM618390025WA SM618390026WA SM618390027WA SM618390028WA SM618390029WA SM618390030WA SM618470001WA SM618470024WA SM618470025WA SM618470026WA SM618490024WA SM618510003WA SM618510009WA SM619100004WA SM619110026WA SM619110027WA SM618380005WA SM618380006WA SM619100011WA SM618360008WA SM618360010WA SM618360012WA SM618360029WA SM618360030WA SM618370055WA SM619170002WA SM619170003WA SM618380039WA SM618370001WA SM618370002WA SM618380013WA SM618460039WA SM618380012WA SM618380019WA SM618370012WA SM619110001WA SM619170052WA SM619200046WA SM619200047WA SM619220001WA SM619240008WA SM619240009WA SM619240010WA SM619240011WA SM619150007WA SM618480035WA CARESTATION 650 A2, Model Number 1012-9650-002, No UDI, OUS only Mfg. Lot or Serial # SM718450028WA SM718450029WA SM718450030WA SM718450031WA SM718450032WA SM718450033WA SM718340013WA SM718340014WA SM718340015WA SM718340019WA SM718340020WA SM718370012WA SM718410018WA SM718510028WA SM718510029WA SM718490037WA SM718380010WA SM718380011WA SM718380006WA SM718380004WA SM718490029WA SM718490030WA SM718490032WA SM718490033WA SM718490034WA SM718490035WA SM718340018WA SM718360037WA SM718360038WA SM718360042WA SM718360043WA SM718470055WA SM718490024WA SM718490025WA SM718490026WA SM718490027WA SM718490028WA SM718370013WA SM719070010WA SM719070011WA SM719070012WA SM719070013WA SM719070014WA SM719070015WA SM718380002WA SM718380003WA SM719230023WA SM719230024WA SM719230025WA SM718490036WA SM718370074WA SM718370075WA SM719240003WA SM718370031WA SM718370032WA SM718370033WA SM718370073WA SM718470056WA SM718510030WA SM719110001WA SM719110003WA SM719110004WA SM718380005WA SM719135001WA SM719135002WA SM718470011WA CARESTATION 650C A2, Model Number 1012-9655-002, No UDI, OUS only Mfg. Lot or Serial # SM818370001WA SM818480001WA SM818480005WA
Recall started: Nov. 25, 2019
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: The firm initiated their field notification by letter on November 25, 2019. The letter states the reason for recall and provides the following safety instructions: You can continue to use the anesthesia system. - If you observe the message Ventilate Manually! , change from mechanical to manual ventilation. At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device. Contact your GE Healthcare representative for repair of the device. - Perform the planned maintenance (PM) every 12-months at a minimum per the User s Reference Manual which includes inspection of the cable connection. Note: This inspection step is included in the annual PM described in the Technical Reference Manual. Performing this step in the PM would confirm the integrity of the cable connection. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm will be correcting the units. The firm issued a Press Release on January 13, 2020.
Recall number: Z-0814-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0813-2020, Z-0814-2020. The agency record governs; check it and the company before acting.

Report a mistake on this page