Recall Z-0248-2016 ยท FWZ Operating Room Accessories Table Tray
Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning
| Date | Nov 9, 2015 (initiated Aug 17, 2015) |
| Status | Terminated |
| Reason | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events. |
| Root cause | Under Investigation by firm |
| Action | MAQUET sent an "Urgent Product Recall Medical Device Removal" notice and "Medical Device Removal Response Form" dated August 17, 2015 via UPS to affected customers. The notification identified the issue and the affected product. The notification instructed customers to read the notification and disseminate the information provided to all the users of the device; examine their inventory to determine if they have the Adjustable Positioning Elements; if so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet; and fill out and sign the acco |
| Quantity | United States (3 sets); Rest of World (47 sets) |
| Distribution | Worldwide Distribution - US including AL, CA, MO and Internationally to Australia, Brazil, Canada, China, Croatia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, Singapore, South Africa and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.