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U.S. Department of Health and Human Services

Class 1 Device Recall Carestation 620/650/650c A2

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  Class 1 Device Recall Carestation 620/650/650c A2 see related information
Date Initiated by Firm November 25, 2019
Date Posted January 23, 2020
Recall Status1 Terminated 3 on November 30, 2023
Recall Number Z-0814-2020
Recall Event ID 84438
Product Classification Gas-machine, anesthesia - Product Code BSZ
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.
Code Information 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       
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Heathcare Service
800-437-1171
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 280 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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