9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Reported: November 11, 2020 Initiated: September 17, 2020 #Z-0314-2021
Product Description
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Reason for Recall
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 37 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
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.. Recalled by GE Healthcare, LLC. Units affected: 37 devices.
Why was this product recalled? ▼
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0314-2021.
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