Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA device recall Z-2703-2017 · posted 2017-05-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
- Action taken
- 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
- Status
- Terminated
- Product code
- BSZ
- Quantity 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: Alg
- Date initiated
- 2017-05-02
- Date posted
- 2017-05-24
- Date terminated
- 2018-02-13
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Carestation 620/650/650C (K151570) | Datex-Ohmeda, Inc. | 2016-01-21 |