FDA recall Z-2585-2021

Product

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Reason for recall

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Distribution

Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

Key facts

Status

Terminated

Initiation date

2021-08-25

Report date

2021-10-06

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2585-2021