GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product recall
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide…
Why was GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product recalled?
Flow sensors could have damaged tubes in the form of small punctures or cuts.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
- Product
- GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 101 devices
- Distribution
- 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
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)