Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1626-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Product Classification:

Class II

Date Initiated: April 6, 2021

Date Posted: June 2, 2021

Recall Number: Z-1626-2021

Event ID: 87753

Reason for Recall:

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

Status: Terminated

Product Quantity: 10 units

Code Information:

Serial Number: V30446637ACAE, V30446653BE5A, V304441360854, V304457587F98, V304468408502, V304441766F34, V3044555732D7, V30446846E034, V30444034719A, V3044642346EA.

Distribution Pattern:

Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan

Voluntary or Mandated:

Voluntary: Firm initiated