FDA Device recall Z-0813-2020
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support…
- FDA Device
- Class I
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class I recall of Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support… by Ge Healthcare, citing GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-11-25 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Reason
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
Identifiers
| code_info | CARESTATION 620 A1, Model Number 1012-9620-000 Mfg. Lot or Serial # UDI # SM619130003MA 010084068210398521SM619130003MA…CARESTATION 620 A1, Model Number 1012-9620-000 Mfg. Lot or Serial # UDI # SM619130003MA 010084068210398521SM619130003MA11190326 SM619120026MA 010084068210398521SM619120026MA11190321 SM619030025MA 010084068210398521SM619030025MA11190117 SM619020017MA 010084068210398521SM619020017MA11190108 SM619020018MA 010084068210398521SM619020018MA11190108 SM619180019MA 010084068210398521SM619180019MA11190502 SM619020063MA 010084068210398521SM619020063MA11190111 SM619020064MA 010084068210398521SM619020064MA11190111 SM619020065MA 010084068210398521SM619020065MA11190111 SM619110001MA 010084068210398521SM619110001MA11190311 SM618380015MA 010084068210398521SM618380015MA11180918 SM619060074MA 010084068210398521SM619060074MA11190208 SM618460073MA 010084068210398521SM618460073MA11181116 SM619170031MA 010084068210398521SM619170031MA11190422 SM619170032MA 010084068210398521SM619170032MA11190422 SM619170033MA 010084068210398521SM619170033MA11190422 SM618440026MA 010084068210398521SM618440026MA11181101 SM619020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.