Recall Z-1560-2022 ยท CBK Ventilator, Continuous, Facility Use
Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
| Date | Jul 20, 2022 |
| Status | Open, Classified |
| Reason | Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure. |
| Root cause | Software in the Use Environment |
| Action | On July 20, 2022, the firm sent Urgent Medical Device Correction letters to customers. Customers were instructed to examine their inventory immediately to see if they had any of the affected serial numbers on hand. Per the company, customers may continue to use their Ventilator System in accordance to the Users manual with extra attention to the following precautions as listed in chapter 1.2 Safety Guidelines of the User s manual: o The patient must never be left unattended when connected to the ventilator system o Always make sure that a manual resuscitator is readily available The firm has |
| Quantity | 37000 (11089 US) |
| Distribution | Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, De |
| FDA record | Open on fda.gov |