Recall Z-1278-2022 ยท BSZ Gas-Machine, Anesthesia
Getinge Usa Sales Inc
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
| Date | Jun 23, 2022 (initiated May 2, 2022) |
| Status | Terminated |
| Reason | Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated. |
| Root cause | Component design/selection |
| Action | Maquet Critical Care AB/Getinge initiated a voluntary Medical Device Correction Letter on 5/2/22. . Examine your inventory immediately to determine if you have any of the Flow-c and/or Flow-e anesthesia system(s) with the serial numbers as listed in this notice. . You may continue use of the affected device ensuring that the recommended daily system check out (SCO) and pre-anesthesia checkout procedures are followed as listed in the Operators Manual. . Check for functionality of the suction unit. If you detect a cracked or broken on/off switch before starting a new case, the anesthesia m |
| Quantity | 17 units US |
| Distribution | US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, Mar 18, 2020 |