Recall record at a glance
| Official record | Z-2703-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare, LLC |
| Report date | Jul 19, 2017 |
| Recall initiation date | May 2, 2017 |
| Quantity | 3,448 (334 US; 3,114 OUS) |
| Location | Waukesha, WI, United States |
Official product description
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Why the product was recalled
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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