FDA Device recall Z-0754-2020
CARESCAPE Respiratory Module E-sCO
- 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-sCO 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-0754-2020 |
| 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-sCO
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 # SGV19241006HA 010084068210417321SGV19241006HA11190614 SGV19241003HA 010084068210417321SGV1…Mfg. Lot or Serial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|
|---|
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-0754-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.