Recall Z-0776-2024 ยท BTI Compressor, Air, Portable
Datex-Ohmeda, Inc.
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
| Date | Jan 30, 2024 (initiated Dec 29, 2023) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root |
| Root cause | Component design/selection |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to consignees on 12/29/2023. The notice explained the safety issue with the device and requested the following actions be taken: GE HealthCare recommends that the EVair and EVair 03 (Jun-Air) compressors are not used to supply air to ventilators for neonatal and infant patients (0-2 years of age). Since the elevated levels of formaldehyde are observed when the compressors are used at higher room temperatures, GE HealthCare is also lowering the maximum room air temperature for operation of the compressors from 40oC (104oF) to 30oC |
| Quantity | 1294 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.