FDA recall Z-2301-2018

Product

OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

Reason for recall

The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2018-05-01

Report date

2018-07-04

Termination date

2020-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2018