CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and re
FDA device recall Z-2617-2014 · posted 2014-09-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
- Action taken
- Consignees were sent on 8/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 36106 dated August 8, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions you can contact Technical Support at 1-800-558-7044 or your local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CCL
- Quantity affected
- 748 (307 units US, 441 units OUS)
- Distribution
- US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, P
- Date initiated
- 2014-08-08
- Date posted
- 2014-09-09
- Date terminated
- 2015-09-08
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONITOR B40 (K133576) | Ge Medical Systems China Co., Ltd. | 2014-02-21 |
| CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (K123195) | GE Healthcare Finland Oy | 2013-02-28 |