Reported May 22, 2013 · Terminated
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova…
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 Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published 005178429-017200000000000151— 000000000SN155000000000000320000000000011900000000000145 00000009C20117 0000009C2M014500000000000125005178429-0158 000628844-0003 005178429-0162 0000009C2M0117 005178429-0207 0000010C2M0031 005178429-0227 005178429-0220 005178429-0228 005178429-00190000000000012800000000000118005178429-0156 005178429-0202000000000001380000000000002900000575126BU8 0005178429-149 005178429-015700000000000030005178429-0215 005178429-0169 0000009C2M0147 005178429-0023 0005178429-141 0005178429-148 0000009C2M0146 000062844-001700000000000024005178429-0173 00000569580BU4 00000560327BU9000000000001430000009C2M0031 00000382877BU9 00000008C20355 005178429-0219 0005178429-003 005178429-0191 0000009C2M0171 00000566927BU0 0005178429-166 00000108C20034 00000519105BU1 00000536810BU5 00000007C20182 00000007C20190 00000453918BU5 00000460973BU1 00000465429BU9 00000464107BU2 00000519092BU1 00000548597BU4 00000551441BU9 00000008C20172 0000009C2M0205 0000009C2M0042 0000009C2M0044 00000007C20051 00000510196BU9 00000007C20200 00000008C20061 00000519126BU7 00000007C20030 00000007C20279 00000477809BU8 00000007C20380 00000008C20342 00000555132BU0 00000519091BU3 00000007C20354 00000007C20319 0000009C2M0161 00000007C20157 00000464041BU3 00000465847BU2 00000477754BU6 00000477756BU1 00000477806BU4 00000489682BU5 00000489707BU0 005178429-0152 00000570447BU3 005178429-0186 0000010BC20040 005178429-0122 005178429-0139 00000557843BU0 005178429-0183 005178429-0222 005178429-0235 00000007C20184 00000008C20042 00000408330BU9 00000520061BU3 00000520075BU3 00000007C20395 00000008C20090 00000008C20183 00000498685BU7 00000477833BU8 00000489764BU1 00000489778BU1 00000458498BU3 00000007C20136 00000007C20236 00000464579BU2 00000562718BU7 00000536796BU6 00000498683BU2 00000007C20168 00000007C20305 00000007C20363 00000046582BU1 00000466841BU4 0000010C2M0034 0000010C2M0109 00000007C20329 00000498680BU8 00000477841BU1 005178429-0034 0000009C2M0153 00000055098VE8 00000099665VE2 00000459665BU6 00000007C20014 00000536812BU1 00000007C20192 00000008C20022 0000009C2M0025 00000419206BU8 00000007C20163 0000009C2M0050 00000008C20315 00000536811BU3 00000007C20164 00000007C20368 00000008C20196 00000008C20254 00000008C20055 00000008C20175 00000007C20372 - Amount recalled
- 713
Where it was sold
Why it was recalled
While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
This product could cause temporary or reversible health problems — stop using it.
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