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Siemens Medical Solutions USA, Inc recalls COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Recalled March 4, 2020 · FDA recall Z-1346-2020 · Siemens Medical Solutions USA
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. · FDA Class II
Units
64 Worldwide/26 Domestic
Sold at
Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Description
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.
Product
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →