—#179419

Product

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060633
Affected lot / code info: Software versions 2.0.49, 2.0.50, 2.0.51

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2020-01-16
Terminated: 2021-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179419. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.