Siemens COHERENCE Oncologist Software Recall for Incorrect Dose Positioning
Siemens is recalling COHERENCE Oncologist software due to a calculation error that could lead to incorrect patient repositioning and radiation dose delivery to the wrong location.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because it involves a medical device defect that could result in significant injury through incorrect radiation dose delivery to the wrong location, consistent with the rubric for significant injury reports or high-risk device defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the COHERENCE Oncologist software, Model Nos. 07333680 & 07351898. The recall involves software versions 2.0.49, 2.0.50, and 2.0.51. A total of 64 units were distributed worldwide, with 26 units distributed domestically in the United States.
The recall is issued because a potential safety issue arises when an offset calculation is followed by a filter operation. Correcting the image alignment after this specific sequence of operations results in incorrect offset values. This error could lead to the incorrect repositioning of the patient and the delivery of radiation dose to the wrong location.
The affected software was distributed domestically to California, Florida, Georgia, Iowa, Massachusetts, Michigan, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, and West Virginia. It was also distributed to foreign locations worldwide. Users of this software should contact Siemens Medical Solutions USA, Inc. for further instructions on correcting the issue.
The recalled product
- Product
- COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Manufacturer
- Siemens Medical Solutions USA, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Software versions 2.0.49
- 2.0.50
- 2.0.51
Distribution
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