Philips issues urgent safety notice for Allura systems

Royal Philips (NYSE:PHG) issued a set of field safety notices for its Allura Xper system, icnluding the FD, Centron, Clarity and CV20 models over issues with failing alarms and unexpected system movements.

The Integris Allura Xper system is designed for cardiovascular and vascular X-ray imaging applications as well as interventional procedures such as percutaneous transluminal coronary angioplasties, stent placements, embolizations, pacemaker implantations and electrophysiology.

The medical giant said it received complaints that were verified through internal testing involving uncontrolled geometry movements when the system is not switched on or off regularly.

The issue affects all Allura Xper systems with release R8.1.1.5, R8.1.16 and R7.2.8, the company said in the notice.

The company warned that the operator may perceive “gradually increased sluggishness,” followed by uncontrolled movement after activating the IU controls.

Philips urged customers to regularly restart the system as mentioned, and to follow all current safety measures to avoid patient or bystander safety issues. Rebooting the system, Philips said, will also restore standard operation.

The company plans to patch the software to correct the issue, and said it will contact customers to begin the implementation.

In a 2nd recall notice, Philips warned that a software error can lead to the device not sounding the audible 5-minute fluoroscopy signal. The error was reported by customers and verified by the company, though no injuries were reported.

The error affects a range of devices and software releases, as well as product codes 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722022, 722023, 722025, 722026, and 722400.

The company urged users to maintain realtime observation and dose information during processing. Philips said it will be correcting the issue through company service engineers and software changes, according to the notice.

In early December, the FDA published a Class II recall notice for a select number of Integris Allura Xper vascular systems. The system is specifically designed for ‘hybrid’ rooms, and use of the platform in operating rooms is restricted, according to the federal watchdog.

The recall was issued for 3 units, with serial numbers 1181, 1188 and 1189, according to the FDA. No reports of injuries or specific device malfunctions interfering with procedures were mentioned in the FDA filing.

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