Z-0463-2019Class I

GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b)...

Name: Z-0463-2019 GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b)...
Creator: GE Healthcare, LLC
Published: 2018-10-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-10-05 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860... on 2018-10-05. FDA classified it as Class I and gives the reason as "The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the...". 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-0463-2019
Classification: Class I
Status: Terminated
Initiated: 2018-10-05
Posted: 2018-11-30
Terminated: 2024-04-29
Recalling firm: GE Healthcare
Product: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, GE Healthcare, initiated an "URGENT MEDICAL DEVICE CORRECTION" on 10/05/2018 by letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Follow the safety instructions and If you have any incorrect ISGs, return to GE Healthcare or destroy on site, and complete and return the attached Customer Response form checking box #2 to indicate that you do have affected ISGs. E-mail the completed form to [email protected]. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. 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. The firm initiated a new recall notice identifying a new issue on 02/01/2019
Quantity in commerce: 1140 units (307 units in US)
Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Honduras, Hungary, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: a) 2066713-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130 b) 2083208-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0463-2019	Class I	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code CBK

K142679Class IICarescape R860Datex-Ohmeda, Inc. / cleared 2015-06-12

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)