PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Philips Azurion system; Software Version Number: R3.1; — Reason: Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand. — Status: Ongoing