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
Recall
- Recall Number
- Z-0036-2024
- Event Number
- 93005
- Firm
- Getinge Usa Sales Inc
- FEI Number
- 3013876692
- Product Code
- FQO
- Status
- Open, Classified
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- September 6, 2023
- Posted
- October 4, 2023
- Address
- 1 Geoffrey Way, Wayne, NJ, 07470-2035
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
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
Maquet GMBH / Getinge initiated Urgent Medical Device Correction letter on 9/6/23 via Fed'X. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Meera Mobile Operating Table with the serial numbers listed in this notice. Maintain awareness on this notice and related actions until your operating table has been updated to ensure effectiveness of the corrective action. Please complete and sign the attached MEDICAL DEVICE CORRECTION- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 800-746-3592 Please forward this information to all current and potential Meera Mobile Operating Table users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Getinge has developed a correction to address this issue. A Getinge Service representative will contact you to schedule the correction. This work will be done at no cost to your facility. If you have any questions, please contact your Maquet /Getinge representative Getinge Technical Support at (888) 943-8872 (press option 4, then option 2, then option 1) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
US Nationwide distribution.
224 units