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GE Healthcare, LLC Recall 89576

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

GE Healthcare, LLC Recall 89576 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0808-2022
Event ID89576
Event DescriptionGE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Product TypeDevices
DistributionWorldwide 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, Kenya, Republic of Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovak Republic, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Recall ReasonIf the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Device Classification20220323
Device Code InfoVersion 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; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604.
Center Classification Date20220316
Recall Initiation Date20220128
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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