Reported Jun 1, 2016 · Terminated
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
- Lot codes and dates
- Mfg Lot or Serial # System ID Mfg Lot or Serial # System IDNot Avaialble GON4345699 Not Avaialble GON4110095 Not Avaialble
664365BU4804828CATH4669085BU3573815D730668484BU9714FVDISC672437BU1775770CATHLAB30000HXF3001331801714DIS73000000632172BU3203694IGS73000000633128BU4309624FT600000633831BU3619532DISCOVERY00000630288BU9303426IR0000HXF3001333949250DISC73000000637023BU3214345IGS7300000HXE9001300650723SC100000646169BU3330375HOR00000638611BU4414649DIS100000646917BU5720854IGS73000000614688BU0610954OR100000622054BU5423778DISC646007BU5206VMDISCOVERY100000637724BU6281BAYIGS730
Not Avaialble 082416060019 00000653092BU7 082416100080 00000651999BU5 082416120043 Not AvaialbleDZ1104VA0300000661681BU7030078RX0500000651337BU8190059RX3000000659126BU7210060RX140000HXE9001292613722D73000000650197BU708241604006100000653093BU508241604006900000668482BU3082416040074
Not Avaialble SA2454VA01 00000615500BU6 0847160010 0000014A2A0010 AE1477VA01 Not Avaialble GON4316421 00000642197BU8 10692VAS01 00000638812BU8 00169VAS01 Not Avaialble 00584VAS0608241620001900000618688BU6M54866AG100000614687BU2A41855260000013A2A0001M4048022200000623224BU3M416047600000663234BU3M9483814500000646918BU3S4160010100000650095BU3HC4348XR1100000671395BU2HC4348XR1400000660146BU2HU1205VA0300000627794BU1IE1147VA0100000672728BU3B512073700000642198BU6YV2000BAPFI0033-0011XV649425BU600000653091BU9XVE14287001
- Mfg Lot or Serial # System ID Mfg Lot or Serial # System ID
- Amount recalled
- 25
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 non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional 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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