Chinese regulators warn about a malfunction in Philip's Pinnical3 software that can affect medication dosages in the radiation therapy devices.
In certain conditions the system may not invalidate the control point dose after the user has modified medication dose level, according to a warning issued by Hong Kong Dept. of Health.
The products affected were in the Pinnacle3 9, 9.2, and 9.4 IFU, all distributed in Hong Kong, according to local regulators. The company is handing out an addendum to its instruction manual that outlines how users can manually invalidate the control point dose.
Hong Kong regulators asked healthcare providers to contact the supplier if problems are identified.
Earlier this year Philips announced a Class I recall in the U.S. of its Ingenuity TF PET/CT, a diagnostic imaging system.
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