Reported Sep 23, 2015 · Terminated
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be…
Bayer 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: Bayer Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
- Lot codes and dates
- Catalog numbers
ART 700 PEDLART 700 TABLART 700 OCSwhich utilize Software Version SW 005.006_SH
- Affected serial numbers
71 of 71 codes
203292057010114820392204252042730046100945100186212553008620025101153101159207141008732043710003310024920333100511101206100002100890101208203232091420342101721007420195201962085020929101106300203002430033202521008720851100009100864100335100952030220306100013209181001412015810078420735204221011492084220018101114100056100075
- Catalog numbers
- Amount recalled
- 71
Where it was sold
- Nationwide
Why it was recalled
Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.
This product could cause temporary or reversible health problems — stop using it.
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