Recall Z-1553-2025 ยท KPR System, X-Ray, Stationary
Philips North America Llc
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
| Date | Apr 11, 2025 (initiated Mar 10, 2025) |
| Status | Open, Classified |
| Reason | Potential for collimator to fall as a result of incorrect installation. |
| Root cause | Under Investigation by firm |
| Action | Consignees received an URGENT MEDICAL DEVICE CORRECTION NOTICE dated 3/7/25. The notice instructs customers of safety precautions to take during scan preparation to ensure devices are fit for use. If consignees notice that the laser from the collimator or crosshairs of the collimator's light field is not able to align with the silkscreen on the front cover of the detector, consignees are to immediately stop use and call their Philips representative. The provided notice is to be posted near affected systems and circulated to all device users. Philips will reach out to consignees to schedule an |
| Quantity | 83 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federatio |
| FDA record | Open on fda.gov |