Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning all Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems. The affected product codes are 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722034, 722035, 722038, 722039, 722058 and 722400.
The safety alert informs users that the use of the above systems regarding live images and still images can lead to still images being interpreted as live Images. If it were to re-occur, it could adversely affect the outcome of a clinical procedure.
This can happen when:
- While doing fluoroscopy, the user presses the single shot exposure pedal, resulting in a single shot still image being displayed on the screen. The user does not realize that the single shot exposure pedal is still active, and that exposure therefore is still active. By design, exposure imaging takes priority over fluoroscopy imaging, so no fluoroscopy is started until the exposure pedal is released. At the same time the user does not realize that live X-ray imaging is not active, although the still image icon is displayed and all legally required live X-ray indicators (such as dose rate, X-ray active icon, fluoro timer, and audible signal —X-ray buzzer-) are inactive.
- While a fluoroscopy pedal is pressed and fluoroscopy is active, the user (accidently) presses a second fluoroscopy pedal and then releases the first fluoroscopy pedal. Upon releasing the first fluoroscopy pedal, the system stops live imaging. The user does not realize that the first fluoroscopy pedal was still pressed when pressing the second fluoroscopy pedal. At the same time the user does not realize that live X-ray imaging is not active, although the still image icon is displayed and all legally required live X-ray indicators (such as dose rate, X-ray active icon, fluoro timer, audible signal —X-ray buzzer-) are inactive.
According to the manufacturer, the system is working fully within specification and accordance with its intended use. The manufacturer will inform users via the field safety notice (FSN) about the presence of the live and still image indications on the system as mentioned in the Instructions for Use. Users are advised to follow the recommended actions in the FSN.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 November 2015