FDA Device recall Z-0579-2018

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

FDA Device
Class II
ongoing
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 by Ge Medical Systems China, citing possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0579-2018
Classification	Class II
Status	ongoing
Initiated	2017-10-11
Published	2018-02-21
Last updated	2026-09-13 11:54 UTC
Company	Ge Medical Systems China
Distribution	AL, AR, AZ, CA, CO, CT, DC, DE, 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, VT, WA, WI, WV

Product

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

Reason

Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

Identifiers

code_info	Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers… Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA SM717200075MA SM717200072MA SM717200073MA SM717200074MA SM617300054MA SM716390006MA SM716390007MA SM716390008MA SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717020023MA SM717020024MA SM717020025MA SM717200052MA SM716300041MA SM716300040MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM616400001MA SM716380022MA SM716380023MA SM716380024MA SM616250007MA SM616460048MA SM616460049MA SM617240035MA SM617240034MA SM617170052MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM616460022MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM7170200

code_info

Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers…

Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA SM717200075MA SM717200072MA SM717200073MA SM717200074MA SM617300054MA SM716390006MA SM716390007MA SM716390008MA SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717020023MA SM717020024MA SM717020025MA SM717200052MA SM716300041MA SM716300040MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM616400001MA SM716380022MA SM716380023MA SM716380024MA SM616250007MA SM616460048MA SM616460049MA SM617240035MA SM617240034MA SM617170052MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM616460022MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM7170200

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0579-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.