MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur
The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall affecting a risk-of-harm product (surgical operating table) where no injuries or illnesses have been reported to date. The equipment malfunction could disrupt surgical procedures, but the documented consequence is procedural delay rather than documented patient harm.
Plain-English summary
The MEERA CL mobile operating table (Item Number 720001F0), manufactured by Getinge USA Sales Inc, is being recalled due to a software error affecting its IR-Hand Control.
Error code 50037 may occur sporadically when the table is controlled via the IR-Hand Control, causing the table to stop moving. When this malfunction occurs during a surgical procedure, the table becomes unresponsive to positioning commands, potentially disrupting surgical workflow.
The recall affects 22 units with serial numbers 1059 through 1091. Affected units have been distributed worldwide, including throughout the United States and to approximately 40 other countries.
Healthcare facilities using affected MEERA CL tables should verify their equipment's serial number and contact the manufacturer, Getinge USA Sales Inc, for further information and corrective instructions.
The recalled product
- 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
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- equipment-malfunction
- operational-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04046768136793 S/N: 1059 through 1091
Distribution
Distributed nationwide across the United States.
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