Z-0313-2021 Class II Ongoing
FDA device recall Z-0313-2021 was initiated by GE Healthcare, LLC on September 17, 2020 and is designated Class II. Reason for recall: Flow sensors could have damaged tubes in the form of small punctures or cuts. The recall status is ongoing. Affected quantity: 101 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 17, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101 devices
Product Description
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
Reason for Recall
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Distribution Pattern
U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom
Code Information
Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)