Class 2 Device Recall GE Healthcare CARESCAPE

• Date Initiated by Firm: January 28, 2022
• Date Posted: March 16, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0808-2022
• Recall Event ID: 89576
• 510(K)Number: K162012
• Product Classification: Display, cathode-ray tube, medical - Product Code DXJ
• Product: GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
• Code Information: Version 2.0.x (v2.0.0, v2.0.1, v2.0.2, or v2.0.3) with serial numbers beginning with SKN for the MAI700 Integrated, UDI 00840682109666 and serial numbers beginning with SNF for the MAI700 Integrated, UDI 0100840682109604; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604.
• FEI Number: 2126677
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
• FDA Determined Cause: Software design
• Action: The recalling firm began issuing the notification letters on 1/28/2022 via FedEx in the U.S. to the following titles within the affected accounts: Director of Biomedical/Clinical Engineering, Chief of Nursing, Health Care Administrator/Risk Manager. The letter contained a black box at the top saying the document contains important information for the product and to ensure all potential users in the facility are made aware of this safety notification and recommended actions. The letter informed the recipient of the safety issues and the actions to be taken. The actions included that it was important to ensure the staff continues to be aware of the serious risks if an unapproved keyboard is used with the CSCS v2.0. They are to ensure all users who interact with CSCS v2.0 are fully aware of, understand, and always follow the instructions provided in the letter. The instructions included that the CARESCAPE Central Station v2.0 with the GE-approved keyboard that is shipped with every CARESCAPE Central Station can continue to be used. Characteristics of the approved GE keyboard were provided for identification. If the recipient is not using a GE-approved keyboard with the CSCS v2.0, they are to follow instructions which include: (1) Ensure it is not muted and steps are provided to confirm it is not muted; (2) Replace any unapproved keyboard with a GE-approved keyboard; (3) If the unapproved keyboard cannot be replaced immediately, (a) Ensure the mute key is not pressed as it will silence all audible alarms; and b) Post these instructions at each CSCS v2.0. The instructions are also listed in Appendix A at the end of the letter. In addition, Appendix B at the end of the letter shows the part numbers for the GE-approved keyboards that can be used with the CARESCAPE Central Station V2.0. Affected Product Details are provided which lists the encompassed software versions, the Model Identifier, and where to find the three-letter Product Code identifier that is found
• Quantity in Commerce: 10,445 units
• Distribution: Worldwide distribution - US nationwide, including Puerto Rico. There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cote d'lvoire, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, Nigeria, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DXJ