Reported Aug 7, 2019 · Terminated
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide…
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?
- GE Pristina Serena - Product UsagePristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions
- Lot codes and dates
Serial# 738192BU4738574BU3734192BU8733706BU6718590BU3735558BU9738023BU1737211BU3739178BU2733600BU1738696BU4738793BU9738695BU6734169BU6733707BU4 and 732113BU6
- Amount recalled
- 16
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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