Recall Z-1346-2020— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1346-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-16

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-01-16, terminated 2021-01-04. It names one FDA 510(k) clearance: K060633. Product: COHERENCE Oncologist, Model Nos. 07333680 & 07351898. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-16
Terminated: 2021-01-04
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K060633 — COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0Siemens Medical Solutions USA, Inc.·cleared 2006-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.