PlainRecalls
FDA Devices Moderate Class II Terminated

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Reported: July 19, 2017 Initiated: May 2, 2017 #Z-2703-2017

Product Description

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Reason for Recall

Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
3,448 (334 US; 3,114 OUS)
Distribution
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1. Recalled by GE Healthcare, LLC. Units affected: 3,448 (334 US; 3,114 OUS).
Why was this product recalled?
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Which agency issued this recall?
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2703-2017.