FDA Device recall Z-2703-2017
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 by Ge Healthcare, citing carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2703-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-02 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI |
Product
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Reason
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Identifiers
| code_info | Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM6164…Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM616430024MA SM616200020MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM617010108MA SM616270021MA SM616270022MA SM617020019MA SM617020020MA SM617020021MA SM616460047MA SM616340001MA SM616340002MA SM616340039MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM616250006MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM616460030MA SM616460028MA SM616460029MA SM616410043MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617060084MA SM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2703-2017%22
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