Recall Z-0580-2018— GE Medical Systems China Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2017-10-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2. Reason: Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems..
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-10-11
- Firm location
- Wuxi, China
Product description
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Reason for recall
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.