MEERA CL mobile operating table - Designed for the placement and positioning of the patient immed...
FDA Recall #Z-0461-2025 — Class II — October 3, 2024
Product Description
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: 710001B2
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
Recalling Firm
Getinge Usa Sales Inc — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
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.
Code Information
UDI-DI: 04046768136304 S/N: 252 - 254
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated