FDA recall Z-0458-2025

Getinge Usa Sales Inc · Class II · device

Product

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0

Reason for recall

Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of", Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Panama, Peru, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.

Key facts

Status
Ongoing
Initiation date
2024-10-03
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2025