Z-0311-2021 Class II Ongoing
FDA device recall Z-0311-2021 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: 2 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
- 2 devices
Product Description
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
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)