Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and

FDA device recall Z-0814-2020 · posted 2020-01-23 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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.

Action taken

The firm initiated their field notification by letter on November 25, 2019. The letter states the reason for recall and provides the following safety instructions: You can continue to use the anesthesia system. - If you observe the message Ventilate Manually! , change from mechanical to manual ventilation. At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device. Contact your GE Healthcare representative for repair of the device. - Perform the planned maintenance (PM) every 12-months at a minimum per the User s Reference Manual which includes inspection of the cable connection. Note: This inspection step is included in the annual PM described in the Technical Reference Manual. Performing this step in the PM would confirm the integrity of the cable connection. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm will be correcting the units. The firm issued a Press Release on January 13, 2020.

Root cause

Process control

Status

Terminated

Product code

BSZ

Quantity affected

280 units

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, C

Date initiated

2019-11-25

Date posted

2020-01-23

Date terminated

2023-11-30

Location

Waukesha, WI