FDA recall Z-0642-2024

Product

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Reason for recall

A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

Distribution

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

Key facts

Status

Ongoing

Initiation date

2023-12-07

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Audubon, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2024