Reported Oct 23, 2013 · Terminated
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended…
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 Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
- Lot codes and dates
- Mfg Lot or Serial # System ID62134LCV+
00000026767YY4201982LCA00000068001YY7901384LCA00000033988YY7914737LCA00000034024YY0954LCA100000031679YY4708216LLCA00000952037WK0630856LCN00000320794BU108240601000200000346260BU3DR-27820-CO00000991021WK7LB1160VA0100000058879BU893004794600000484712WK5145300000529468WK1915685LCA00000528385WK808240604000300000526149WK066324TC00000497670WK0M401705100000512202WK31616LCA00000528587WK9
BPEP 00000063736YY3 MCTHKGMN265 of 265 codes
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
BPANGIO 00000000288MC1 FHORLCL6 00000000089MC3 563421CATHLAB6 00000000562MC9 BPEP563 of 563 codes
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
141,261 of 1,261 codes
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
293 of 293 codes
973365CATH00000000PROTO9ECXV1406C00000109896MO1909865INNOVA200000109911MO8909865INNOVA100000109915MO9617754IN100000109921MO7404712EI100000109906MO808241604000200000109907MO608241604000300000114888MO108301659067022900000114891MO5JO1034VA0100000109904MO300105VAS0100000146340M05561548CL200000146329MO8864455GMIN100000128823MO2864455GMIN200000128779MO6205783BCL300000128692MO1207626CL100000128649MO1213726CATH00000128653MO3213977INNOVA400000146335MO5214320INNOVA00000128717MO6214590INNOVA00000128829MO9215448INNOVA00000120219MO1215861LC200000000517MC3217258CATH00000000173MC5217464INNOVA00000128741MO6229259INOV100000128795M02229386INOV100000000367MC3251435ICV400000120204MO3253627INNOVA200000146341U03254519I2K00000128811MO7262569INNOVA00000000175MC0
- Mfg Lot or Serial # System ID
- Amount recalled
- 2184 (1063 US. 1121 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
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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