Agency classClass IOur severity:Critical FDA (Devices)·Z-0776-2024·Announced 2024-02-07

Medical Device Compressor Kits Recalled for Elevated Formaldehyde Levels

GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I classifications indicate Critical severity regardless of reported illnesses or whether test conditions represent typical clinical use.

Plain-English summary

GE HealthCare is recalling certain EvAir compressor kits (EvAir and EvAir 03/Jun-Air models) used with CARESCAPE R860 and Engström Carestation/Pro ventilators. The recall was initiated after preliminary testing revealed elevated formaldehyde levels when these optional compressors are used with the affected ventilators.

The elevated formaldehyde levels were observed during preliminary testing at elevated room temperature (40°C/104°F) at the lowest possible flow condition (2 L/min with minimum bias flow and no supplemental oxygen). GE HealthCare notes that these test conditions are not representative of typical clinical use. A total of 1,294 units in various electrical configurations have been distributed worldwide.

GE HealthCare is continuing to evaluate the root cause for these elevated formaldehyde levels. The company is taking this action to further reduce the potential for patient exposure to formaldehyde from these devices.

The recalled product

Product: 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…
Manufacturer: Datex-Ohmeda, Inc.
Category: Medical Device — Respiratory Equipment Compressor
Hazard: formaldehyde
Affected units: 1,294

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) DISS/CEE 7/7 230V 50/60 HZ
Model Number M1230849
UDI/DI *TBP*
Serial Numbers: GEB08691
GEB08778
GEB08726
GEB08791
GEB08782
GEB08780
GEB08651
GEB08694
GEB08776
GEA05881
GEA05877
GEA05883
GEA05882
GEA05880
GEA04101
GEA05302
GEA04586

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Datex-Ohmeda, Inc.

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