Reported Jul 1, 2015 · Terminated
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed…
Siemens Medical Solutions USA, Inc.
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: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406
Is this the product you have?
- Artis zee/ zeego systems
- Product UsageUsage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
- Lot codes and dates
- model numbers10094135 10094141 10094139 10094142 10094143
- with serial numbers
475 of 475 codes
124002154502135746153172153315153317153318137165153992153335135120137282135322153101153102154616137226153166154536135000137103137118153700154096154454137461154715135914153834154789154779153194154532157449136085158108135927137510157136154157135209153199140106154721154722137193153887157988154571153269135935135953158091135200135201135279153191153252135169135879
- Amount recalled
- 475
Where it was sold
- Nationwide
Why it was recalled
There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
This product could cause temporary or reversible health problems — stop using it.
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