Meera Mobile Operating Table May Move Unexpectedly During Surgery
Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.
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: Class II medical device with a functional safety defect that could cause unintended movement during surgery. Although no injuries have been reported, the hazard poses a reasonably foreseeable risk of harm to patients and operating room personnel, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling the Meera Mobile Operating Table, Model 7200.01F2. The device is designed to support and position patients during surgical interventions, examinations, and treatments. This recall affects 224 units distributed nationwide across the United States.
Under certain operating conditions, a specific sequence of commands on the control unit may activate the traction drive unintentionally. This can cause the operating table to move on its own for up to 7 seconds. Such unintended movement poses a risk of injury to patients and operating room personnel during surgical procedures.
Healthcare facilities using affected units should immediately discontinue use of devices matching the recalled serial numbers. Contact Getinge Usa Sales Inc for instructions on repair, replacement, or return of the equipment. Verify that your device's serial number is not included in the recall list before resuming surgical use.
The recalled product
- 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
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- unintended-movement
- device-malfunction
Distribution
Distributed nationwide across the United States.
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