MEERA CL operating table may stop unexpectedly during surgical procedures
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
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: FDA Class II recall of a surgical device that stops unexpectedly. No injuries or illnesses reported. Per the rubric, risk-of-harm products without reported injury are classified as High (score 3).
Plain-English summary
The MEERA CL operating table may stop moving unexpectedly due to error code 50037 appearing on the IR-Hand Control. When this error occurs, the table's movement halts and may cause procedural delays during surgery or treatment.
Getinge Usa Sales Inc has recalled 3 units of the MEERA CL operating table (Item Number 710001B2) with serial numbers 252-254. The affected units were distributed worldwide, including throughout the United States.
If you have one of the affected units, contact Getinge Usa Sales Inc for further instructions on addressing this issue. No injuries or illnesses have been reported in connection with this error.
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: 710001B2
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- device-malfunction
- control-system-error
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: 04046768136304 S/N: 252 - 254
Distribution
Distributed nationwide across the United States.
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