Recall Z-0463-2019 ยท CBK Ventilator, Continuous, Facility Use
GE Healthcare, LLC
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 v
| Date | Nov 30, 2018 (initiated Oct 5, 2018) |
| Status | Terminated |
| Reason | 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 | 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 Recall34095.InspiratorySG@ge.com. Please ensure that all potential users in your facility are made |
| Quantity | 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, Greec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142679 | CARESCAPE R860 Datex-Ohmeda, Inc., Jun 12, 2015 |