Recall Z-0813-2020 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
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.
| Date | Jan 23, 2020 (initiated Nov 25, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 3319 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, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatem |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151570 | Carestation 620/650/650C Datex-Ohmeda, Inc., Jan 21, 2016 |