Agency classClass IOur severity:Severe FDA (Devices)·Z-0754-2020·Announced 2020-01-22

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Measurement Errors

GE Healthcare is recalling 167 CARESCAPE Respiratory Module E-sCO units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

Plain-English summary

GE Healthcare, LLC is recalling 167 units of the CARESCAPE Respiratory Module E-sCO. The recall was initiated because the displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect. This defect could result in up to 50% measurement error in the EtO2/FiO2 values.

The affected units were distributed in the United States and numerous countries outside the US, including 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 the United Kingdom.

Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should follow the instructions provided by GE Healthcare for remediation or replacement.

The recalled product

Product: CARESCAPE Respiratory Module E-sCO
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Respiratory Monitor
Hazard: measurement-error
Affected units: 167

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · GE Healthcare, LLC

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