FDA Device recall Z-0808-2022
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001 by Ge Healthcare, citing if the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0808-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-28 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
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.
Identifiers
| 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…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0808-2022%22
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