Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
Reported: June 19, 2019 Initiated: March 29, 2019 #Z-1753-2019
Product Description
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
Reason for Recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 825 (38 US and 787 OUS) in total
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.. Recalled by GE Healthcare, LLC. Units affected: 825 (38 US and 787 OUS) in total.
Why was this product recalled? ▼
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1753-2019.
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