Recall Z-1560-2022— Getinge Usa Sales Inc
Class I · Ongoing
Class I FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-07-20. It names 2 FDA 510(k) clearances: K201874, K192604. Product: 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. 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..
- Recalling firm
- Getinge Usa Sales Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-07-20
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K192604 — Servo-air 4.0 Ventilator System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.