Recall Z-0036-2024— Getinge Usa Sales Inc
Class II · Ongoing
Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-09-06. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Getinge Usa Sales Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-06
- Firm location
- Wayne, NJ, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.