FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Recall number
- Z-1346-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Status
- Terminated
- Initiated
- 2020-01-16
- Posted
- not on file
- Terminated
- 2021-01-04
- 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.
- Root cause
- Software Design Change
- Action
- 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.
- 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.
- Lot, serial or model codes
- Software versions 2.0.49, 2.0.50, 2.0.51
- 510(k) numbers
- ["K060633"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28