Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2016 - (Recall #: Z-0804-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.

Product Classification:

Class I

Date Initiated: December 10, 2015

Date Posted: March 2, 2016

Recall Number: Z-0804-2016

Event ID: 73137

Reason for Recall:

Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.

Status: Terminated

Product Quantity: 7 units within US

Code Information:

Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400 Serial numbers (2743, 2852, 2854, 2855, 2856, 2858

Distribution Pattern:

US Nationwide in the states of CA, NY, and OR

Voluntary or Mandated:

Voluntary: Firm initiated