Z-0315-2021 Class II Ongoing
FDA device recall Z-0315-2021 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: 4794 units.
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
- 4794 units
Product Description
Flow Sensor Service Part, Catalog 2089610-001-S
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). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)