FDA Device recall Z-0755-2020
CARESCAPE Respiratory Module E-sCOVX
- FDA Device
- Class I
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class I recall of CARESCAPE Respiratory Module E-sCOVX by Ge Healthcare, citing displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0755-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-09-27 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
CARESCAPE Respiratory Module E-sCOVX
Reason
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Identifiers
| code_info | Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV1…Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV19266019HA11190626 SGV14404046HA Not Applicable |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0755-2020%22
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