990 recalls tagged with “adult product”.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips recalls 670 Azurion 7 B12 X-ray imaging systems after finding the wired foot switch may fail to start imaging. The issue affects 106 US units and 564 in other countries. Hospitals should stop using the device and await manufacturer guidance.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing