Reported Jun 19, 2019 · Terminated
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
177 of 177 products
Products covered by this recall # Product as published 1 010120RX03 2 030024RX09 3 030047RX02 4 030077RX01 5 030083RX09 6 030106RX09 7 030236RX01 8 030259RX02 9 030557RX01 10 040059RX04 11 040092RX01 12 040200RX04 13 0779 14 080083RX11 15 110018RX01 16 12916PREST 17 130015RX03 18 130136RX01 19 130156RX01 20 13517PREST - Amount recalled
- 825 (38 US and 787 OUS) in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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