Getinge Usa Sales Inc: Medical Device Recall in 2022 - (Recall #: Z-1278-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 2, 2022

Date Posted: June 29, 2022

Recall Number: Z-1278-2022

Event ID: 90250

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.

Status: Terminated

Product Quantity: 17 units US

Code Information:

UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)

Distribution Pattern:

US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia

Voluntary or Mandated:

Voluntary: Firm initiated