Z-0759-2020Class I

CARESCAPE Respiratory Module E-sCAiOVE

Name: Z-0759-2020 CARESCAPE Respiratory Module E-sCAiOVE
Creator: GE Healthcare, LLC
Published: 2019-09-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-09-27 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of CARESCAPE Respiratory Module E-sCAiOVE on 2019-09-27. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0759-2020
Classification: Class I
Status: Terminated
Initiated: 2019-09-27
Posted: 2020-01-10
Terminated: 2023-09-26
Recalling firm: GE Healthcare
Product: CARESCAPE Respiratory Module E-sCAiOVE
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: 1) Connect the module to the host device; 2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes; 3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions; 4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and 5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform. 6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. Contact GE Healthcare Service or your local Service Representative. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 14 unit
Distribution: US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
Product codes and lots: Mfg. Lot or Serial # SGV19295006HA 010084068210430221SGV19295006HA11190717 SGV19255001HA 010084068210430221SGV19255001HA11190618 SGV19295019HA 010084068210430221SGV19295019HA11190717 SGV19255002HA 010084068210430221SGV19255002HA11190618 SGV19255004HA 010084068210430221SGV19255004HA11190618 SGV19255010HA 010084068210430221SGV19255010HA11190618 SGV19255017HA 010084068210430221SGV19255017HA11190618 SGV19255019HA 010084068210430221SGV19255019HA11190618 SGV16385015HA 010084068210430221SGV16385015HA11160919 SGV15285005HA Not Applicable SGV19285017HA 010084068210430221SGV19285017HA11190710 SGV19285019HA 010084068210430221SGV19285019HA11190710 SGV19285007HA 010084068210430221SGV19285007HA11190710 SGV19259708HA Not Applicable

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0759-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0755-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0756-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0757-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0758-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0759-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0760-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code CCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)