FDA recall Z-1346-2020

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-01-16

Report date

2020-03-04

Termination date

2021-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2020