COHERENCE Oncologist recall
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Why was COHERENCE Oncologist 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 2.0.49, 2.0.50, 2.0.51
- Product
- COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 64 Worldwide/26 Domestic
- Distribution
- Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)