Recall Z-1278-2022— Getinge Usa Sales Inc

Name: FDA recall Z-1278-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-02

Class I · Terminated

Class I FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-05-02, terminated 2024-08-06. It names one FDA 510(k) clearance: K191027. Product: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700. 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..

Recalling firm: Getinge Usa Sales Inc
Classification: Class I
Status: Terminated
Initiated: 2022-05-02
Terminated: 2024-08-06
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB·cleared 2020-03-18

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

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.