FDA Device recall Z-0814-2020

Carestation 620/650/650c A2 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 A2 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-0814-2020
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 A2 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 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA S… CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA SM618370005WA SM618370006WA SM618370010WA SM618370070WA SM618370071WA SM618380001WA SM618380002WA SM618380008WA SM618380009WA SM618380010WA SM618380011WA SM618450033WA SM618480061WA SM618500014WA SM619110035WA SM618360022WA SM618360027WA SM618360028WA SM618370020WA SM618370021WA SM618370022WA SM618370023WA SM618370051WA SM618370052WA SM618370053WA SM618370056WA SM618360007WA SM619030013WA SM619030014WA SM619030015WA SM619030016WA SM619040001WA SM619150001WA SM618430007WA SM618440004WA SM618480064WA SM618390031WA SM619100010WA SM618420021WA SM618420022WA SM618420023WA SM618420024WA SM618480063WA SM619070003WA SM619170051WA SM618460048WA SM619070001WA SM619070002WA SM618410001WA SM618410002WA SM618500015WA SM618450034WA SM618380007WA SM619030007WA SM619110044WA SM619120001WA SM619135003WA SM618440035WA SM619110011W

code_info

CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA S…

CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA SM618370005WA SM618370006WA SM618370010WA SM618370070WA SM618370071WA SM618380001WA SM618380002WA SM618380008WA SM618380009WA SM618380010WA SM618380011WA SM618450033WA SM618480061WA SM618500014WA SM619110035WA SM618360022WA SM618360027WA SM618360028WA SM618370020WA SM618370021WA SM618370022WA SM618370023WA SM618370051WA SM618370052WA SM618370053WA SM618370056WA SM618360007WA SM619030013WA SM619030014WA SM619030015WA SM619030016WA SM619040001WA SM619150001WA SM618430007WA SM618440004WA SM618480064WA SM618390031WA SM619100010WA SM618420021WA SM618420022WA SM618420023WA SM618420024WA SM618480063WA SM619070003WA SM619170051WA SM618460048WA SM619070001WA SM619070002WA SM618410001WA SM618410002WA SM618500015WA SM618450034WA SM618380007WA SM619030007WA SM619110044WA SM619120001WA SM619135003WA SM618440035WA SM619110011W

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-0814-2020%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.