FDA recall Z-0036-2024

Getinge Usa Sales Inc · Class II · device

Product

Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

Reason for recall

Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-09-06
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0036-2024