Recall Z-0092-2021 ยท CBK Ventilator, Continuous, Facility Use
Getinge Group Logistics America, LLC
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
| Date | Sep 17, 2020 |
| Status | Open, Classified |
| Reason | A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. |
| Root cause | Device Design |
| Action | On September __, 2020, the firm issued an Urgent Medical Device Recall letter to affected customers. Distributors were instructed to forward the information to all current and potential Servo-i Ventilator System users and biomedical staff within hospitals/facilities. Customers were asked to examine their inventory immediately to determine if they have any products with the listed serial numbers. For affected units, an alternate means of nebulization would need to be readily available and used until the unit correction can be performed by the Getinge Service Technician if nebulization via the |
| Quantity | 431 units |
| Distribution | Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123149 | SERVO-I VENTILATOR SYSTEM Maquet Critical Care AB, Jun 20, 2014 |