Recall Z-0459-2025— Getinge Usa Sales Inc

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2024-10-03. FDA's recall record names no specific 510(k) clearance for this event. 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: 720001F2. Reason: 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
Classification
Class II
Status
Ongoing
Initiated
2024-10-03
Firm location
Wayne, NJ, United States

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: 720001F2

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.