FDA recall Z-0808-2022

Product

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

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.

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.

Key facts

Status

Ongoing

Initiation date

2022-01-28

Report date

2022-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2022