Reported Aug 9, 2023 · Ongoing
Field Upgrade Kits
GE OEC Medical Systems, Inc.
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 OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
Field Upgrade Kits
3 products · 19 lot codes
5451208RIU, 9 INCH, TOSHIBA
13 recalled lot codes
801651028017195580173514801624538018395080151733801635478017153280156410801766501053051410544933380167595
5485304SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA
2 recalled lot codes
10557644118687327
5761613SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
4 recalled lot codes
1028301410152211105108003105114645. OEC 9800
- Amount recalled
- 16
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
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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