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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0808-2022 |
| Event ID | 89576 |
| Event Description | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001. |
| Product Type | Devices |
| 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, 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. |
| Quantity | 10,371 |
| Recall Reason | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. |
| Device Classification | 20220323 |
| Device Code Info | 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; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604. |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20220128 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
| Similar To |