Reported Aug 7, 2019 · Terminated
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used 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?
- GE Senographe Pristina - Product UsageSenographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems
- Lot codes and dates
78 of 78 codes
Serial# 716784BU4716785BU1716786BU9716787BU7716788BU5718583BU8718584BU6718585BU3718586BU1718587BU9718588BU7718589BU5718591BU1718592BU9718593BU7718594BU5718595BU2718596BU0718597BU8718598BU6718599BU4718600BU0718601BU8718602BU6722648BU3722649BU1722653BU3722654BU1722655BU8722656BU6722657BU4730124BU5730125BU2730126BU0730292BU0730293BU8730663BU2730664BU0730665BU7732049BU2732050BU0732303BU3732304BU1732305BU8732362BU9732363BU7732448BU6732449BU4732450BU2732727BU3732728BU1733031BU9733903BU9733904BU7734170BU4734206BU6734840BU2735432BU7735779BU1736006BU8
- Amount recalled
- 82
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.
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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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