FDA Device recall Z-0580-2018

Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2

FDA Device
Class II
ongoing
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 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-0580-2018
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 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.

Identifiers

code_info	Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM6… Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2 SM617240004WA-A2 SM717180002WA-A2 SM717250002WA-A2 SM717230002WA-A2 SM717250003WA-A2 SM717250011WA-A2 SM717250010WA-A2 SM817240005WA SM817240003WA SM817240004WA SM617230006WA SM617230066WA SM617230067WA SM617230068WA SM617230069WA SM617230070WA SM617230071WA SM617230072WA SM617230073WA SM617230074WA SM617230075WA SM617230076WA SM617230077WA SM617230079WA SM617230078WA SM617250041WA SM617250040WA SM617230081WA SM617230080WA SM617240009WA SM617240019WA SM617240016WA SM617240017WA SM617240018WA SM617240024WA SM617250012WA SM617250009WA SM617250005WA SM617250003WA SM617250019WA SM617250004WA SM617250010WA SM617250023WA SM617250022WA SM617250024WA SM617250028WA SM617250025WA SM617250026WA SM617250027WA SM

code_info

Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM6…

Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2 SM617240004WA-A2 SM717180002WA-A2 SM717250002WA-A2 SM717230002WA-A2 SM717250003WA-A2 SM717250011WA-A2 SM717250010WA-A2 SM817240005WA SM817240003WA SM817240004WA SM617230006WA SM617230066WA SM617230067WA SM617230068WA SM617230069WA SM617230070WA SM617230071WA SM617230072WA SM617230073WA SM617230074WA SM617230075WA SM617230076WA SM617230077WA SM617230079WA SM617230078WA SM617250041WA SM617250040WA SM617230081WA SM617230080WA SM617240009WA SM617240019WA SM617240016WA SM617240017WA SM617240018WA SM617240024WA SM617250012WA SM617250009WA SM617250005WA SM617250003WA SM617250019WA SM617250004WA SM617250010WA SM617250023WA SM617250022WA SM617250024WA SM617250028WA SM617250025WA SM617250026WA SM617250027WA SM

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-0580-2018%22

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