Reported Mar 4, 2020 · Terminated
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Lot codes and dates
Software versions 2.0.492.0.502.0.51
- Amount recalled
- 64 Worldwide/26 Domestic
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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