FDA Device recall Z-0756-2020
CARESCAPE Respiratory Module E-sCAiO
- 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-sCAiO 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-0756-2020 |
| 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-sCAiO
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 # SGV19240073HA 010084068210418021SGV19240073HA11190611 SGV19280017HA 010084068210418021SGV1…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-0756-2020%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.