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Terminated

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

FDA Recall Z-2703-2017 · Posted 2017-05-24

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2017-05-02
Date Terminated2018-02-13
Product Quantity3,448 (334 US; 3,114 OUS)

Reason for Recall

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

Firm Action

Consignees were sent on 5/2/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34082 dated May 2, 2017. The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering & Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. GE Healthcare will correct affected products. GE Healthcare representative will contact the firms to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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