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Recall Observatory FDA recall evidence

Device product

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Z-1346-2020

January 16, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 84795
Status
Terminated
Classification
Class II
Quantity
64 Worldwide/26 Domestic
Official record key
device-enforcement:Z-1346-2020

Official wording

Reason: 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.

Code information: Software versions 2.0.49, 2.0.50, 2.0.51

Distribution pattern: Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.