FDA-Device2020-03-04Class II
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Siemens Medical Solutions USA, Inc
Hazard
A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.
Sold states
Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Affected count
64 Worldwide/26 Domestic
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2020Don't want to check this manually?
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