Solna, SE · 4 510(k) clearances · 4 recalls (3 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Class II | Gastroenterology, Urology | 1 | 2026-08-26 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | Class II | Anesthesiology | 1 | 2023-07-06 |
| CBK | Ventilator, Continuous, Facility Use | Class II | Anesthesiology | 1 | 2021-04-20 |
| BSZ | Gas-Machine, Anesthesia | Class II | Anesthesiology | 1 | 2020-03-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-06-24 | Class II | Ongoing | Z-2860-2026 | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 68… | — | Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient rec… |
| 2025-05-30 | Class I | Ongoing | Z-2015-2025 | Servo-u MR Ventilator System. Model Number: 6888800. | — | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and … |
| 2025-05-30 | Class I | Ongoing | Z-2014-2025 | Servo-n Ventilator System. Model Number: 6694800. | — | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and … |
| 2025-05-30 | Class I | Ongoing | Z-2013-2025 | Servo-u Ventilator System. Model Number: 6688600. | — | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-26 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | PIF | Class II | Gastroenterology, Urology |
| 2023-07-06 | K230173 | Servo-air Lite Ventilator System | MNT | Class II | Anesthesiology |
| 2021-04-20 | K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | CBK | Class II | Anesthesiology |
| 2020-03-18 | K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | BSZ | Class II | Anesthesiology |