Reported Jan 21, 2015 · Terminated
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Discovery IGS 730 & Discovery IGS 740
- Discovery IGS 730The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures
- Discovery IGS 740The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures
- Lot codes and dates
- Mfg Lot or Serial # System IDNot available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available
0000013C2A0001203694IGS7300000011C2A0005610954OR10000014A2A0009718283D7400000014A2A0007SO42082280000014A2A0016SO42422940000014A2A0004206VMDISCOVERY1
Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS018241604006100000011C2A003A41855260000012C2A0002M41604760000014A2A0008S4160010100000612802BU9M54866AG1
- Mfg Lot or Serial # System ID
- Amount recalled
- 24 ( 7 US, 17 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
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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