GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-0808-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 28, 2022

Date Posted: March 23, 2022

Recall Number: Z-0808-2022

Event ID: 89576

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.

Status: Ongoing

Product Quantity: 10,445 units

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated