Z-1496-2020 Class II Terminated
FDA device recall Z-1496-2020 was initiated by Siemens Medical Solutions USA, Inc on February 14, 2020 and is designated Class II. Reason for recall: A software issue could potentially cause the stand and table movements to be blocked. The recall status is terminated (terminated April 20, 2021). Affected quantity: 1452 worldwide (638 US).
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 14, 2020
- Termination Date
- April 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1452 worldwide (638 US)
Product Description
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis 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.
Reason for Recall
A software issue could potentially cause the stand and table movements to be blocked.
Distribution Pattern
US Nationwide distribuiton.
Code Information
Serial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022