Z-1339-2019 Class II Terminated
FDA device recall Z-1339-2019 was initiated by Siemens Medical Solutions USA, Inc on April 9, 2019 and is designated Class II. Reason for recall: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. The recall status is terminated (terminated April 23, 2020). Affected quantity: 459 (116 US).
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 9, 2019
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 459 (116 US)
Product Description
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of 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 with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
Code Information
Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235