FDA Device recall Z-0758-2020
CARESCAPE Respiratory Module E-sCAiOE
- 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-sCAiOE 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-0758-2020 |
| 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-sCAiOE
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 # SGV19254028HA 010084068210413521SGV19254028HA11190618 SGV19274009HA 010084068210413521SGV1…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-0758-2020%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.