CARESCAPE Central Station recallZ-0808-2022 · GE Healthcare, LLC · initiated Jan 28, 2022

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number

Z-0808-2022

Status

Open, Classified

Initiated by the company

Jan 28, 2022

Posted by the FDA

Mar 16, 2022

Recalling firm

GE Healthcare, LLC

Quantity

10,445 units

Product code

DXJ

FDA submissions

K162012

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.

Product description

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• CARESCAPE Central Station V2 Standard MAS 700

  Ge Medical Systems Information Technologies, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
  3 recalls0 reports
• CARESCAPE Central Station V2 Integrated MAI 700

  Ge Medical Systems Information Technologies, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
  3 recalls0 reports

Product lines

• CARESCAPE Central StationGe Medical Systems Information Technologies, Inc. · 4 models · 1 reports · 6 recalls

Other devices under the same FDA submission

2 devices cleared under K162012 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• CARESCAPE CENTRAL STATION MAI800

  Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable
  3 recalls0 reports
• CARESCAPE CENTRAL STATION MAI800

  Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable
  2 recalls1 death1 report