Reported Oct 21, 2020 · Terminated
Artis zee or Artis Q systems (listed below) - Product Usage
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 · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
Artis zee or Artis Q systems (listed below) - Product Usage
13 of 13 products
| Model / number | Product as published |
|---|---|
10848282 | Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE |
10848281 | ARTIS Q CEILING |
10848280 | Artis Q floor |
10848283 | ARTIS Q ZEEGO |
10848355 | ARTIS Q.ZEN BIPLANE |
10848354 | ARTIS Q.zen ceiling |
10848353 | Artis Q.zen floor |
10094141 | Artis zee Biplane |
10094137 | Artis zee ceiling |
10094135 | Artis zee floor |
10094135 | Artis zee floor |
10094139 | Artis zee multi-purpose |
10280959 | Artis zeego |
- Lot codes and dates
- Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P
- Serial Numbers
124 of 124 codes
103222103285103286105016109016109021109069109105109107109158109163109189109221109300109331109367109371109393109416109451109460109504109505109520111005111104111106111117111120111123111125117014117030117117117123117129117134117303117309117310117314117325117329117330121008121058121062121071121375121377121378121383121405121417121442123010123014123023123049123208
- Amount recalled
- 124 U.S
Why it was recalled
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure
This product could cause temporary or reversible health problems — stop using it.
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