Siemens Medical Solutions USA, Inc COHERENCE Oncologist, Model Nos. 07333680 & 07351898 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Software versions 2.0.49, 2.0.50, 2.0.51
Products Sold
Software versions 2.0.49, 2.0.50, 2.0.51
Siemens Medical Solutions USA, Inc is recalling COHERENCE Oncologist, Model Nos. 07333680 & 07351898 due to A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, GA, IA, MA, MI, NE, NV, NJ, NY, OH, OK, PA, SD, TN, WV
Page updated: Jan 10, 2026