Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Recall
- Recall Number
- Z-1553-2025
- Event Number
- 96435
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- KPR
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 10, 2025
- Posted
- April 11, 2025
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Potential for collimator to fall as a result of incorrect installation.
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 inspection of devices by field service engineers. Engineers may also replace the collimator, if necessary. Consignees with questions are to call Philips Customer Care Solutions Center at 1-800-722-9377 from Monday through Friday (8:00 AM to 8:00 PM EST).
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 Federation, Slovenia, South Africa, Spain, Thailand, United Kingdom, Vietnam.
83 units