The Recall Desk
CriticalFDA (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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 HZ,
Manufacturer
Datex-Ohmeda, Inc.
Category
Medical Device — Respiratory Equipment Compressor
Hazard
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 →

Related recalls

Same manufacturer · Datex-Ohmeda, Inc.

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Same hazard · formaldehyde

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